Enforcement record
The government paper trail.
Public FDA warning letters and import alerts, DOJ prosecutions, FTC actions, and recalls affecting peptide and research-chemical sellers. Every entry is a real government record with its source linked. We report the action — we never add an accusation of our own, and a match to a specific vendor is only made when we’re confident.
383
Actions on record
5
Severe (proven)
3
Tracked vendors affected
2
Agencies
U.S. DOJ · Enforcement action · guilty plea · 2025-12-10
Guilty plea — misbranded/unapproved drugs; SARMs that contained testosterone
Named: Matthew Kawa and Jennifer Stechkober (Paradigm Peptides / Paradigm R.E. LLC) · not matched to a tracked vendor
On Dec 10, 2025, Matthew Kawa (owner of Paradigm Peptides / Paradigm R.E. LLC, paradigmpeptides.com) and Jennifer Stechkober pleaded guilty in the U.S. District Court, N.D. Indiana. Investigators determined many products sold as SARMs actually contained testosterone (a controlled substance), and the SARM, hCG, and peptide products were unapproved new drugs (sold Apr 2019–Mar 2024). Sentencing pending.
U.S. DOJ · Enforcement action · guilty plea · 2021-11-17
Guilty plea — anabolic steroids/SARMs sold as supplements; conspiracy
Named: Blackstone Labs LLC; Phillip Braun; Aaron Singerman · not matched to a tracked vendor
Blackstone Labs LLC and founders Phillip Braun and Aaron Singerman pleaded guilty (S.D. Florida, 2021) to conspiracy to distribute controlled substances and sell unapproved new drugs. Products marketed as supplements were illegal anabolic steroids/SARMs/prohormones. Forfeitures totaling ~$6.9M; Singerman later sentenced to 54 months.
U.S. DOJ · Enforcement action · guilty plea · 2020-12-22
Guilty plea — unlawful distribution of SARMs
Named: Brett Becker and Accelerated Genetix, LLC · not matched to a tracked vendor
Brett Becker and Accelerated Genetix, LLC pleaded guilty (W.D. Virginia, Dec 2020) to distributing unapproved new drugs with intent to defraud the FDA. They unlawfully distributed SARMs (Ostarine, Ligandrol) 2016–2019; Becker forfeited ~$3.5M.
U.S. DOJ · Enforcement action · guilty plea · 2020-11-24
Guilty plea — unlawful distribution of SARMs
Named: Brian Michael Parks and MedFitRX, Inc. · not matched to a tracked vendor
Brian Parks and MedFitRX, Inc. (now MedFit Sarmacuticals) pleaded guilty (W.D. Virginia, Nov 2020) to distributing unapproved new drugs with intent to defraud the FDA. They unlawfully distributed SARMs (MK-2866, LGD-4033, RAD-140) 2017–2019; Parks forfeited $1.2M.
U.S. DOJ · Enforcement action · convicted · 2019-05-28
Convicted — misbranded DNP 'fat burner' (NOT a SARMs conviction)
Named: Scott Edward Cavell (CEO, Enhanced Athlete) · not matched to a tracked vendor
Scott Cavell, CEO of Enhanced Athlete, was sentenced (E.D. California, 2019) to three years for introducing misbranded drugs — specifically 2,4-Dinitrophenol (DNP) sold as a weight-loss 'fat burner' falsely labeled fertilizer. Note: this conviction is for DNP, not SARMs; the separate SARMs matter was an FDA seizure/investigation with no confirmed filed charge.
FDA · Recall · 2026-04-24
FDA Class II recall — Liraglutide Injection
Named: Lupin Pharmaceuticals Inc. · not matched to a tracked vendor
FDA recall D-0541-2026 (Class II) by Lupin Pharmaceuticals Inc.. Product: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.. Reason for recall: Presence of particulate matter: a white thread-like structure in the cartridge Voluntary: Firm initiated · Distribution: Nationwide within U.S · Status: Ongoing
FDA · Warning letter · 2026-03-31
FDA warning letter — unapproved retatrutide/tirzepatide
Named: Gram Peptides (Bernard Gramlich) · not matched to a tracked vendor
FDA reviewed grampeptides.com in early 2026 and found 'Retatrutide', 'Tirzepatide', and 'Bacteriostatic Water for Injection', deemed unapproved new drugs.
FDA · Recall · 2026-03-06
FDA Class II recall — Semaglutide-Glycine-Cyanocobalamin Injectable
Named: PAYLESS COMPOUNDERS, LLC · not matched to a tracked vendor
FDA recall D-0471-2026 (Class II) by PAYLESS COMPOUNDERS, LLC. Product: Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: OR · Status: Ongoing
FDA · Recall · 2026-02-26
FDA Class II recall — Semaglutide Inj.
Named: New Life Pharma LLC · not matched to a tracked vendor
FDA recall D-0393-2026 (Class II) by New Life Pharma LLC. Product: Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: OH · Status: Ongoing
FDA · Recall · 2026-02-26
FDA Class II recall — Tirzepatide Inj
Named: New Life Pharma LLC · not matched to a tracked vendor
FDA recall D-0394-2026 (Class II) by New Life Pharma LLC. Product: Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: OH · Status: Ongoing
FDA · Recall · 2026-02-26
FDA Class II recall — Tirzepatide Inj
Named: New Life Pharma LLC · not matched to a tracked vendor
FDA recall D-0395-2026 (Class II) by New Life Pharma LLC. Product: Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: OH · Status: Ongoing
FDA · Recall · 2026-02-26
FDA Class II recall — Semaglutide Inj
Named: New Life Pharma LLC · not matched to a tracked vendor
FDA recall D-0392-2026 (Class II) by New Life Pharma LLC. Product: Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: OH · Status: Ongoing
FDA · Recall · 2026-02-13
FDA Class II recall — Semaglutide
Named: Harbin Jixianglong Biotech Co., Ltd. · not matched to a tracked vendor
FDA recall D-0380-2026 (Class II) by Harbin Jixianglong Biotech Co., Ltd.. Product: Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong…. Reason for recall: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Ongoing
FDA · Recall · 2026-02-13
FDA Class II recall — Semaglutide
Named: Harbin Jixianglong Biotech Co., Ltd. · not matched to a tracked vendor
FDA recall D-0379-2026 (Class II) by Harbin Jixianglong Biotech Co., Ltd.. Product: Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North…. Reason for recall: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Ongoing
FDA · Recall · 2025-12-19
FDA Class II recall — Wegovy (semaglutide) Injection
Named: Novo Nordisk Inc. · not matched to a tracked vendor
FDA recall D-0245-2026 (Class II) by Novo Nordisk Inc.. Product: Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14. Reason for recall: Presence of Particulate Matter: Hair was found in a prefilled syringe Voluntary: Firm initiated · Distribution: Nationwide within the United States. · Status: Ongoing
FDA · Recall · 2025-12-19
FDA Class II recall — Wegovy (semaglutide) Injection
Named: Novo Nordisk Inc. · not matched to a tracked vendor
FDA recall D-0244-2026 (Class II) by Novo Nordisk Inc.. Product: Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14. Reason for recall: Presence of Particulate Matter: Hair was found in a prefilled syringe Voluntary: Firm initiated · Distribution: Nationwide within the United States. · Status: Ongoing
FDA · Warning letter · 2025-12-12
FDA warning letter — products marketed as SARMs
Named: Dynamic Health Group dba SARMS AMERICA · not matched to a tracked vendor
FDA reviewed sarmsamerica.co in November 2025 and found products marketed as SARMs (Ostarine, MK-677, Cardarine, LGD-4033), deemed unapproved new drugs.
FDA · Warning letter · 2025-12-12
FDA warning letter — products marketed as SARMs
Named: Pinnacle Professional Research dba Pinnacle Peptides · not matched to a tracked vendor
FDA reviewed pinnaclepeptides.com in November 2025 and found products marketed as SARMs (S4 Andarine, LGD-4033, MK-2866), deemed unapproved new drugs.
FDA · Warning letter · 2025-12-12
FDA warning letter — products marketed as SARMs
Named: TITAN SARMS LLC · not matched to a tracked vendor
FDA reviewed titansarms.com in November 2025 and found products marketed as SARMs (Ligandrol, Testolone, Andarine), deemed unapproved new drugs.
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0116-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0115-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0114-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0119-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
Recall — GHK-Cu (copper peptide) for injection, sterility (Class II)
Named: GenoGenix LLC · not matched to a tracked vendor
FDA drug-enforcement recall (D-0051-2026, Class II, ongoing) of GenoGenix 'GHK-Cu for Injection' for lack of assurance of sterility, part of a mass compounded-injectable recall that also swept in research-style peptides (retatrutide, tirzepatide).
FDA · Recall · 2025-10-15
Recall — retatrutide for injection, sterility (Class II)
Named: GenoGenix LLC (Retatrutide for Injection) · not matched to a tracked vendor
FDA drug-enforcement recall (D-0093-2026, Class II, ongoing) of GenoGenix 'Retatrutide for Injection' 60mg/10mL for lack of assurance of sterility.
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0117-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
FDA Class II recall — Semaglutide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0118-2026 (Class II) by ProRx LLC. Product: Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-10-15
FDA Class II recall — Tirzepatide Injection
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0120-2026 (Class II) by ProRx LLC. Product: Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: TX and UT · Status: Ongoing
FDA · Recall · 2025-09-16
FDA Class I recall — Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Named: IntegraDose Compounding Services LLC · not matched to a tracked vendor
FDA recall D-0015-2026 (Class I) by IntegraDose Compounding Services LLC. Product: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1. Reason for recall: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Warning letter · 2025-09-08
FDA warning letter — unapproved tianeptine products
Named: PureRawz (Seann Gloss) · matched to PureRawz
FDA reviewed purerawz.co in August 2025 and found multiple Tianeptine products; despite 'for laboratory and research use only' labeling, FDA deemed them unapproved new drugs intended for human use.
FDA · Recall · 2025-07-30
FDA Class II recall — BPC-157/Thymosin Beta-4 for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0086-2026 (Class II) by GenoGenix LLC. Product: BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical…. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Thymosin Beta-4 (TB4) for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0087-2026 (Class II) by GenoGenix LLC. Product: Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Cerebrolysin for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0071-2026 (Class II) by GenoGenix LLC. Product: Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Sermorelin Lyophilized powder for reconstitution
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0090-2026 (Class II) by GenoGenix LLC. Product: Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — BPC-157 for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0085-2026 (Class II) by GenoGenix LLC. Product: BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Glutathione Magnesium for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0052-2026 (Class II) by GenoGenix LLC. Product: Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Tesamorelin for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0088-2026 (Class II) by GenoGenix LLC. Product: Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Semaglutide for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0091-2026 (Class II) by GenoGenix LLC. Product: Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Oxytocin for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0077-2026 (Class II) by GenoGenix LLC. Product: Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Glutathione Preserved for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0053-2026 (Class II) by GenoGenix LLC. Product: Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Tirzepatide
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0092-2026 (Class II) by GenoGenix LLC. Product: Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyop…. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Semaglutide with B12 for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0083-2026 (Class II) by GenoGenix LLC. Product: Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — GHK-Cu (Copper Peptide) for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0051-2026 (Class II) by GenoGenix LLC. Product: GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-30
FDA Class II recall — Retatrutide for Injection
Named: GenoGenix LLC · not matched to a tracked vendor
FDA recall D-0093-2026 (Class II) by GenoGenix LLC. Product: Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: US Nationwide. · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0560-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0562-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0557-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0558-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0561-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0554-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0559-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0555-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0553-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide + Cyanocobalamin injection solution
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0564-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0563-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0565-2025 (Class II) by AEQUITA PHARMACY. Product: Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-18
FDA Class II recall — Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Named: AEQUITA PHARMACY · not matched to a tracked vendor
FDA recall D-0556-2025 (Class II) by AEQUITA PHARMACY. Product: Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.. Reason for recall: Lack of Processing Controls. Voluntary: Firm initiated · Distribution: MA · Status: Ongoing
FDA · Recall · 2025-07-09
FDA Class II recall — Semaglutide
Named: Boothwyn Pharmacy LLC · not matched to a tracked vendor
FDA recall D-0609-2025 (Class II) by Boothwyn Pharmacy LLC. Product: Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy. Reason for recall: Subpotent Drug Voluntary: Firm initiated · Distribution: U.S. Nationwide · Status: Ongoing
FDA · Recall · 2025-07-09
FDA Class II recall — Semaglutide
Named: Boothwyn Pharmacy LLC · not matched to a tracked vendor
FDA recall D-0608-2025 (Class II) by Boothwyn Pharmacy LLC. Product: Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy. Reason for recall: Subpotent Drug Voluntary: Firm initiated · Distribution: U.S. Nationwide · Status: Ongoing
FDA · Recall · 2025-07-09
FDA Class II recall — Semaglutide
Named: Boothwyn Pharmacy LLC · not matched to a tracked vendor
FDA recall D-0606-2025 (Class II) by Boothwyn Pharmacy LLC. Product: Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy. Reason for recall: Subpotent Drug Voluntary: Firm initiated · Distribution: U.S. Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — CJC-1295 Injectable
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0475-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Tirzepatide Injections
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0483-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Tirzepatide/Cyanocobalamin Injectable
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0486-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Tirzepatide Injections
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0482-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Tirzepatide/Cyanocobalamin Injectable
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0485-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Tirzepatide Injections
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0484-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Semaglutide/Cyanocobalamin Injectable
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0481-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Semaglutide
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0480-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-05-21
FDA Class II recall — Semaglutide
Named: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · not matched to a tracked vendor
FDA recall D-0479-2025 (Class II) by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Product: Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2025-04-09
FDA Class II recall — Wegovy (semaglutide) injection
Named: Cardinal Health Inc. · not matched to a tracked vendor
FDA recall D-0393-2025 (Class II) by Cardinal Health Inc.. Product: Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd,…. Reason for recall: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. Voluntary: Firm initiated · Distribution: NC, SC, VA · Status: Ongoing
FDA · Warning letter · 2025-02-26
FDA warning letter — unlawful sale of unapproved/misbranded drugs online
Named: USApeptide.com · not matched to a tracked vendor
FDA reviewed usapeptide.com and found it introduced misbranded and unapproved new drugs into interstate commerce in violation of the FD&C Act.
FDA · Warning letter · 2024-12-10
FDA warning letter — unapproved new drugs (semaglutide, retatrutide)
Named: Swisschems · matched to Swiss Chems
FDA reviewed swisschems.is in October 2024 and found it offered 'Semaglutide' and 'Retatrutide' for sale in the U.S. Despite 'research chemicals only' labeling, FDA determined these are unapproved new drugs under the FD&C Act.
FDA · Warning letter · 2024-12-10
FDA warning letter — unapproved GLP-1/weight-loss peptides
Named: Summit Research Peptides · not matched to a tracked vendor
FDA reviewed summitpeptides.shop in October 2024 and found 'Semaglutide', 'Retatrutide', 'Cagrilintide', 'Tirzepatide', and 'Mazdutide' products, all deemed unapproved new drugs.
FDA · Warning letter · 2024-12-10
FDA warning letter — unapproved semaglutide/retatrutide
Named: Prime Vitality, Inc. dba Prime Peptides · not matched to a tracked vendor
FDA reviewed primepeptides.co in October 2024 and found 'Semaglutide' and 'Retatrutide' products, deemed unapproved new drugs despite 'research' labeling.
FDA · Recall · 2024-09-25
FDA Class II recall — Oxytocin 0.9% Sodium Chloride Injection USP
Named: Fresenius Kabi Compounding, LLC · not matched to a tracked vendor
FDA recall D-0021-2025 (Class II) by Fresenius Kabi Compounding, LLC. Product: Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59. Reason for recall: cGMP violations Voluntary: Firm initiated · Distribution: Product was distributed to 125 direct accounts nationwide. · Status: Terminated
FDA · Recall · 2024-08-22
FDA Class II recall — TIRZEPATIDE 60 mg/3mL (20/mg/mL)
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0656-2024 (Class II) by ProRx LLC. Product: TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — Semaglutide
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0650-2024 (Class II) by ProRx LLC. Product: Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0651-2024 (Class II) by ProRx LLC. Product: Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — TIRZEPATIDE 20 mg/2mL (10/mg/mL)
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0655-2024 (Class II) by ProRx LLC. Product: TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0654-2024 (Class II) by ProRx LLC. Product: Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — SEMAGLUTIDE 10mg/4mL (2.5mg/mL)
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0653-2024 (Class II) by ProRx LLC. Product: SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-08-22
FDA Class II recall — SEMAGLUTIDE 5mg/2mL (2.5mg/mL)
Named: ProRx LLC · not matched to a tracked vendor
FDA recall D-0652-2024 (Class II) by ProRx LLC. Product: SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Ongoing
FDA · Recall · 2024-04-20
FDA Class I recall — Tirzepatide 10 mg/0.5 mL Sterile Solution
Named: Revive Rx LLC dba Revive Rx Pharmacy · not matched to a tracked vendor
FDA recall D-0511-2024 (Class I) by Revive Rx LLC dba Revive Rx Pharmacy. Product: Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64. Reason for recall: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Ongoing
FDA · Recall · 2023-10-04
FDA Class III recall — Oxytocin synthetic
Named: Denver Solutions, LLC DBA Leiters Health · not matched to a tracked vendor
FDA recall D-0070-2024 (Class III) by Denver Solutions, LLC DBA Leiters Health. Product: Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70. Reason for recall: Labeling: Not Elsewhere Classified Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Terminated
FDA · Recall · 2023-08-17
FDA Class II recall — oxyTOCIN
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1134-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1. Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-08-17
FDA Class II recall — oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1133-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1. Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-08-17
FDA Class II recall — oxyTOCIN 30 units added to Lactated Ringer's 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1132-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1. Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-08-15
FDA Class II recall — Semaglutide/Cyanocobalamin 2mg/0.4mg/mL
Named: TMC Acquisitions LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1105-2023 (Class II) by TMC Acquisitions LLC dba Tailor Made Compounding. Product: Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide within the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0983-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1003-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 20 units added to Lactated Ringer's 1000 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0984-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 10 units added to Lactated Ringer's 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0972-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1013-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 20 units added to 0.9% sodium chloride 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0976-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0973-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 15 units added to Lactated Ringer's 250 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0975-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0986-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2023-07-14
FDA Class II recall — oxyTOCIN 30 units added to Lactated Ringer's 500 mL
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-1012-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Warning letter · 2023-06-12
FDA warning letter — SARMs and injectable peptides (BPC-157, TB-500)
Named: Warrior Labz SARMS (Jeremy Brown) · not matched to a tracked vendor
FDA found warriorlabzsarms.com took orders for SARMs (RAD-140, MK-677, MK-2866, LGD-4033), plus injectable/nasal 'BPC-157' and 'TB-500', all deemed unapproved new drugs.
FDA · Recall · 2023-05-11
FDA Class II recall — Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Named: Revive Rx LLC dba Revive Rx Pharmacy · not matched to a tracked vendor
FDA recall D-0771-2023 (Class II) by Revive Rx LLC dba Revive Rx Pharmacy. Product: Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.. Reason for recall: Sub-potent Drug Voluntary: Firm initiated · Distribution: Nationwide in the US · Status: Ongoing
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0707-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 60 units added to 0.9% sodium chloride 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0711-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0708-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0703-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 40 units added to 0.9% sodium chloride 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0740-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0710-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 20 units added to Lactated Ringer's 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0706-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0702-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0705-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0704-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-28
FDA Class II recall — oxyTOCIN 20 units added to 0.9% sodium chloride 1
Named: Central Admixture Pharmacy Services, Inc. · not matched to a tracked vendor
FDA recall D-0709-2023 (Class II) by Central Admixture Pharmacy Services, Inc.. Product: oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Terminated
FDA · Recall · 2023-04-13
FDA Class II recall — C-Semaglutide 5mg/mL injection
Named: Pharmacy Plus, Inc. dba Vital Care Compounder · not matched to a tracked vendor
FDA recall D-0538-2023 (Class II) by Pharmacy Plus, Inc. dba Vital Care Compounder. Product: C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402. Reason for recall: Lack of assurance of sterility. Voluntary: Firm initiated · Distribution: MS only · Status: Ongoing
FDA · Recall · 2023-04-10
FDA Class III recall — Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Named: SCA Pharmaceuticals · not matched to a tracked vendor
FDA recall D-0555-2023 (Class III) by SCA Pharmaceuticals. Product: Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44. Reason for recall: Subpotent Drug: Out of specification results for low potency was obtained. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-12-22
FDA Class II recall — GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML
Named: Pharmacy Innovations · not matched to a tracked vendor
FDA recall D-0210-2023 (Class II) by Pharmacy Innovations. Product: GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCE…. Reason for recall: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-12-22
FDA Class II recall — SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SE
Named: Pharmacy Innovations · not matched to a tracked vendor
FDA recall D-0236-2023 (Class II) by Pharmacy Innovations. Product: SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy I…. Reason for recall: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-10-07
FDA Class II recall — SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN
Named: Pharmacy Plus, Inc. dba Vital Care Compounder · not matched to a tracked vendor
FDA recall D-0053-2023 (Class II) by Pharmacy Plus, Inc. dba Vital Care Compounder. Product: SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402. Reason for recall: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. Voluntary: Firm initiated · Distribution: AL, LA, MS, and TN · Status: Ongoing
FDA · Recall · 2022-09-20
FDA Class III recall — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride
Named: QuVa Pharma, Inc. · not matched to a tracked vendor
FDA recall D-1544-2022 (Class III) by QuVa Pharma, Inc.. Product: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, T…. Reason for recall: Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-08-26
FDA Class II recall — Sermorelin Acetate 1 MG/ML Injectable
Named: Carolina Infusion · not matched to a tracked vendor
FDA recall D-1518-2022 (Class II) by Carolina Infusion. Product: Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Completed
FDA · Recall · 2022-08-26
FDA Class II recall — Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable
Named: Carolina Infusion · not matched to a tracked vendor
FDA recall D-1519-2022 (Class II) by Carolina Infusion. Product: Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Completed
FDA · Recall · 2022-08-26
FDA Class II recall — Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable
Named: Carolina Infusion · not matched to a tracked vendor
FDA recall D-1520-2022 (Class II) by Carolina Infusion. Product: Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Completed
FDA · Recall · 2022-08-26
FDA Class II recall — Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable
Named: Carolina Infusion · not matched to a tracked vendor
FDA recall D-1521-2022 (Class II) by Carolina Infusion. Product: Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA. · Status: Completed
FDA · Recall · 2022-06-30
FDA Class II recall — Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection
Named: Nephron Sterile Compounding Center LLC · not matched to a tracked vendor
FDA recall D-1273-2022 (Class II) by Nephron Sterile Compounding Center LLC. Product: Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-05-18
FDA Class II recall — Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection
Named: Nephron Sterile Compounding Center LLC · not matched to a tracked vendor
FDA recall D-0964-2022 (Class II) by Nephron Sterile Compounding Center LLC. Product: Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-05-09
FDA Class II recall — Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Mult
Named: Olympia Compounding Pharmacy dba Olympia Pharmacy · not matched to a tracked vendor
FDA recall D-0913-2022 (Class II) by Olympia Compounding Pharmacy dba Olympia Pharmacy. Product: Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30. Reason for recall: Lack of assurance of sterility. Voluntary: Firm initiated · Distribution: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands · Status: Completed
FDA · Recall · 2022-05-09
FDA Class II recall — Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Named: Olympia Compounding Pharmacy dba Olympia Pharmacy · not matched to a tracked vendor
FDA recall D-0902-2022 (Class II) by Olympia Compounding Pharmacy dba Olympia Pharmacy. Product: Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00. Reason for recall: Lack of assurance of sterility. Voluntary: Firm initiated · Distribution: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands · Status: Completed
FDA · Recall · 2022-04-05
FDA Class II recall — LL-37 2 mg/mL (5 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0778-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0780-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — Sermorelin Acetate 1 mg/mL (6 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0781-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — BPC-157 2 mg/mL (5 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0776-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0775-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0777-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-05
FDA Class II recall — Melanotan II 1 mg/mL (10 mL) Injection
Named: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · not matched to a tracked vendor
FDA recall D-0779-2022 (Class II) by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Product: Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA. Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: Nationwide within United States · Status: Terminated
FDA · Recall · 2022-04-04
FDA Class II recall — Sermorelin Acetate
Named: Olympia Compounding Pharmacy dba Olympia Pharmacy · not matched to a tracked vendor
FDA recall D-0797-2022 (Class II) by Olympia Compounding Pharmacy dba Olympia Pharmacy. Product: Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.. Reason for recall: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated Voluntary: Firm initiated · Distribution: Distributed Nationwide in the USA · Status: Terminated
FDA · Recall · 2022-03-23
FDA Class II recall — GONADORELIN (5ML) 0.2 MG/ML INJECTABLE
Named: Drug Depot, Inc., dba APS Pharmacy · not matched to a tracked vendor
FDA recall D-0728-2022 (Class II) by Drug Depot, Inc., dba APS Pharmacy. Product: GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy. Reason for recall: Lack of sterility assurance. Voluntary: Firm initiated · Distribution: Nationwide in the USA including Puerto Rico. · Status: Terminated
FDA · Recall · 2022-03-23
FDA Class II recall — (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE
Named: Drug Depot, Inc., dba APS Pharmacy · not matched to a tracked vendor
FDA recall D-0729-2022 (Class II) by Drug Depot, Inc., dba APS Pharmacy. Product: (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy. Reason for recall: Lack of sterility assurance. Voluntary: Firm initiated · Distribution: Nationwide in the USA including Puerto Rico. · Status: Terminated
FDA · Recall · 2022-03-08
FDA Class II recall — Sermorelin Acetate Lyophilized powder for reconstitution
Named: Olympia Compounding Pharmacy dba Olympia Pharmacy · not matched to a tracked vendor
FDA recall D-0718-2022 (Class II) by Olympia Compounding Pharmacy dba Olympia Pharmacy. Product: Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 731…. Reason for recall: Sub Potent Voluntary: Firm initiated · Distribution: Nationwide in the USA including Puerto Rico. · Status: Terminated
FDA · Recall · 2022-03-07
FDA Class II recall — PT-141 10mg/mL a) 1mL-vial
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1223-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Semaglutide/Cyanocobalamin 5mg/0.2mg/ml
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1225-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Sermorelin/Glycine 2000mcg/5mg/mL
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1227-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Glutathione 200mg/ml
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1243-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Melanotan I 200mcg/mL (2mg/ml)
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1212-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Glutathione 200mg/mL Preservative Free
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1205-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Sermorelin 2000mcg/mL
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1226-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Sermorelin/Glycine 2000mcg/5mg/mL
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1228-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Gonadorelin 100mcg/mL
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1207-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2022-03-07
FDA Class II recall — Semaglutide/Cyanocobalamin 2mg/0.4mg/ml
Named: TMC Acquisition LLC dba Tailor Made Compounding · not matched to a tracked vendor
FDA recall D-1224-2022 (Class II) by TMC Acquisition LLC dba Tailor Made Compounding. Product: Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA and Puerto Rico · Status: Ongoing
FDA · Recall · 2021-10-12
FDA Class II recall — SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL
Named: Vita Pharmacy, LLC dba Talon Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0143-2022 (Class II) by Vita Pharmacy, LLC dba Talon Compounding Pharmacy. Product: SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. Reason for recall: Lack of assurance of sterility Voluntary: Firm initiated · Distribution: United States including Washington, D.C. and Puerto Rico · Status: Terminated
FDA · Recall · 2021-10-12
FDA Class II recall — SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL
Named: Vita Pharmacy, LLC dba Talon Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0144-2022 (Class II) by Vita Pharmacy, LLC dba Talon Compounding Pharmacy. Product: SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. Reason for recall: Lack of assurance of sterility Voluntary: Firm initiated · Distribution: United States including Washington, D.C. and Puerto Rico · Status: Terminated
FDA · Recall · 2021-10-12
FDA Class II recall — CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE
Named: Vita Pharmacy, LLC dba Talon Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0109-2022 (Class II) by Vita Pharmacy, LLC dba Talon Compounding Pharmacy. Product: CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. Reason for recall: Lack of assurance of sterility Voluntary: Firm initiated · Distribution: United States including Washington, D.C. and Puerto Rico · Status: Terminated
FDA · Recall · 2021-10-12
FDA Class II recall — SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL
Named: Vita Pharmacy, LLC dba Talon Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0145-2022 (Class II) by Vita Pharmacy, LLC dba Talon Compounding Pharmacy. Product: SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. Reason for recall: Lack of assurance of sterility Voluntary: Firm initiated · Distribution: United States including Washington, D.C. and Puerto Rico · Status: Terminated
FDA · Recall · 2021-08-13
FDA Class II recall — GLUTATHIONE 200MG/ML MDV
Named: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0038-2022 (Class II) by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Product: GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx. Reason for recall: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Voluntary: Firm initiated · Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT. · Status: Terminated
FDA · Recall · 2021-08-13
FDA Class II recall — ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN
Named: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0033-2022 (Class II) by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Product: ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx. Reason for recall: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Voluntary: Firm initiated · Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT. · Status: Terminated
FDA · Recall · 2021-07-09
FDA Class II recall — Compounded Lyophilized AOD-9604
Named: Innoveix Pharmaceuticals Inc · not matched to a tracked vendor
FDA recall D-0693-2021 (Class II) by Innoveix Pharmaceuticals Inc. Product: Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Completed
FDA · Recall · 2021-07-09
FDA Class II recall — Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injecti
Named: Innoveix Pharmaceuticals Inc · not matched to a tracked vendor
FDA recall D-0692-2021 (Class II) by Innoveix Pharmaceuticals Inc. Product: Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Completed
FDA · Warning letter · 2021-05-18
FDA warning letter — SARMs and undeclared tadalafil
Named: Umbrella (Brendan Mullins) · matched to Umbrella Labs
FDA found the firm's sites directed consumers to umbrellalabs.is selling SARMs (GW-501516, MK-2866, MK-677, RAD-140, S-4), plus tianeptine and kratom; lab analysis found 'Alpha Male Plus' contained undeclared tadalafil. Deemed unapproved/misbranded drugs.
FDA · Recall · 2021-03-22
FDA Class II recall — OZEMPIC (semaglutide) injection
Named: Novo Nordisk Inc · not matched to a tracked vendor
FDA recall D-0617-2021 (Class II) by Novo Nordisk Inc. Product: OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 016…. Reason for recall: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2021-03-22
FDA Class II recall — Saxenda (liraglutide) Injection
Named: Novo Nordisk Inc · not matched to a tracked vendor
FDA recall D-0618-2021 (Class II) by Novo Nordisk Inc. Product: Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 01…. Reason for recall: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2021-03-22
FDA Class I recall — Xultophy 100/3.6 (insulin degludec and liraglutide injection)
Named: Novo Nordisk Inc · not matched to a tracked vendor
FDA recall D-0623-2021 (Class I) by Novo Nordisk Inc. Product: Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536,…. Reason for recall: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2021-03-22
FDA Class II recall — ViCTOZA (liraglutide) injection
Named: Novo Nordisk Inc · not matched to a tracked vendor
FDA recall D-0622-2021 (Class II) by Novo Nordisk Inc. Product: ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit). Reason for recall: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2021-03-15
FDA Class II recall — Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 ta
Named: Cardinal Health Inc. · not matched to a tracked vendor
FDA recall D-0536-2021 (Class II) by Cardinal Health Inc.. Product: Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. Voluntary: Firm initiated · Distribution: FL, GA, SC · Status: Terminated
FDA · Warning letter · 2020-12-07
FDA/FTC warning letter — unapproved COVID-19 claim on 'Thymosin Alpha 1'
Named: Paradigm RE LLC (support@paradigmpeptides.com) · not matched to a tracked vendor
A 2020 joint FDA/FTC letter to Paradigm RE LLC found the website marketed 'Thymosin Alpha 1' to mitigate/prevent/treat COVID-19, deemed an unapproved new drug and misbranded. Note: this concerns a COVID-19/Thymosin claim, not the vendor's SARM/peptide catalog — same operating entity, different product line.
FDA · Recall · 2020-11-30
FDA Class II recall — GHK-CU
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0141-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — LL-37
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0143-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — PT-141
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0130-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — AOD-9604
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0131-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — CJC-1295
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0128-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — BPC-157
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0132-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — THYMOSIN BETA - 4
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0140-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — IPAMORELIN
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0134-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-11-30
FDA Class II recall — CEREBROLYSIN
Named: Advanced Nutriceuticals, LLC · not matched to a tracked vendor
FDA recall D-0139-2021 (Class II) by Advanced Nutriceuticals, LLC. Product: CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Voluntary: Firm initiated · Distribution: CA, CO, FL, IN, KY, OH, TX · Status: Ongoing
FDA · Recall · 2020-05-28
FDA Class II recall — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Us
Named: QuVa Pharma, Inc. · not matched to a tracked vendor
FDA recall D-1302-2020 (Class II) by QuVa Pharma, Inc.. Product: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07. Reason for recall: Subpotent drug - Product did not contain drug. Voluntary: Firm initiated · Distribution: USA Nationwide · Status: Terminated
FDA · Recall · 2020-01-29
Recall — SARM RAD-140 marketed without approval (Class II)
Named: Tuscano and Delucia Group (DBA Entropic Labs) · not matched to a tracked vendor
FDA drug-enforcement recall (D-0800-2020, Class II, terminated) of Entropic Labs 'SARM RAD-140' 20mg capsules for being marketed without an approved NDA/ANDA (contains SARMs). Distributed nationwide.
FDA · Recall · 2020-01-15
FDA Class II recall — Glutathione Injection
Named: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical · not matched to a tracked vendor
FDA recall D-0953-2020 (Class II) by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Product: Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic · Status: Terminated
FDA · Recall · 2019-12-20
FDA Class II recall — CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-88
Named: Assurance Infusion · not matched to a tracked vendor
FDA recall D-0720-2020 (Class II) by Assurance Infusion. Product: CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800. Reason for recall: Lack of sterility assurance. Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-12-20
FDA Class II recall — BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800
Named: Assurance Infusion · not matched to a tracked vendor
FDA recall D-0679-2020 (Class II) by Assurance Infusion. Product: BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800. Reason for recall: Lack of sterility assurance. Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-12-20
FDA Class II recall — IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
Named: Assurance Infusion · not matched to a tracked vendor
FDA recall D-0748-2020 (Class II) by Assurance Infusion. Product: IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800. Reason for recall: Lack of sterility assurance. Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-10-10
FDA Class II recall — Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Named: Innoveix Pharmaceuticals Inc · not matched to a tracked vendor
FDA recall D-0159-2020 (Class II) by Innoveix Pharmaceuticals Inc. Product: Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910. Reason for recall: Lack of Sterility Assurance. Voluntary: Firm initiated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin Acetate 9 mg / Vial
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0099-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin Acetate
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0094-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0100-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL)
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0097-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin Acetate
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0093-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin Acetate 3 mg / Vial
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0098-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Glutathione 30 mL Vial-For IM Use-Hypertonic solution
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0053-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0095-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — OxyTOCIN in 0.9% Sodium Chloride Solution (PF)
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0083-2020 (Class II) by KRS Global Biotechnology, Inc. Product: OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-09-12
FDA Class II recall — Sermorelin 9 mg / GHRP6
Named: KRS Global Biotechnology, Inc · not matched to a tracked vendor
FDA recall D-0096-2020 (Class II) by KRS Global Biotechnology, Inc. Product: Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide · Status: Terminated
FDA · Recall · 2019-08-12
FDA Class II recall — S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN
Named: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0200-2020 (Class II) by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Product: S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2019-08-12
FDA Class II recall — S-GLUTATHIONE 200MG/ML MDV
Named: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0224-2020 (Class II) by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Product: S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2019-08-12
FDA Class II recall — S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN
Named: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · not matched to a tracked vendor
FDA recall D-0223-2020 (Class II) by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Product: S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide in the USA · Status: Terminated
FDA · Recall · 2019-06-26
FDA Class II recall — Glutathione 100 mg/mL Inhalation Solution (PF)
Named: First Pharma Associates LLC dba Riverpoint Pharmacy · not matched to a tracked vendor
FDA recall D-1484-2019 (Class II) by First Pharma Associates LLC dba Riverpoint Pharmacy. Product: Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252. Reason for recall: Lack of Assurance of Sterility. Voluntary: Firm initiated · Distribution: ID, WA only · Status: Terminated
FDA · Recall · 2019-06-19
FDA Class II recall — GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN
Named: RXQ Compounding LLC · not matched to a tracked vendor
FDA recall D-1662-2019 (Class II) by RXQ Compounding LLC. Product: GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0971-81. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA · Status: Terminated
FDA · Recall · 2019-06-19
FDA Class II recall — GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN
Named: RXQ Compounding LLC · not matched to a tracked vendor
FDA recall D-1663-2019 (Class II) by RXQ Compounding LLC. Product: GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0906-30. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: Nationwide USA · Status: Terminated
FDA · Recall · 2019-06-12
FDA Class II recall — Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Named: Infusion Options, Inc. · not matched to a tracked vendor
FDA recall D-1744-2019 (Class II) by Infusion Options, Inc.. Product: Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233. Reason for recall: Lack of Assurance of Sterility Voluntary: Firm initiated · Distribution: NY only · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/GHRP-2 &6 (9-9-9-mg) vials
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1334-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/Ipamorelin 18 mg/15 mg
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1330-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1331-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/GHRP-2 9 mg/6 mg vials
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1332-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/GHRP-2 &6 (9-9-9 mg) vials
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1335-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
FDA · Recall · 2019-05-23
FDA Class II recall — Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials
Named: Pharm D Solutions, LLC · not matched to a tracked vendor
FDA recall D-1333-2019 (Class II) by Pharm D Solutions, LLC. Product: Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846. Reason for recall: Lack of Sterility Assurance. FDA Mandated · Distribution: Nationwide within the United States · Status: Terminated
A record is a fact, not a verdict on the product.
An FDA warning letter usually means a seller marketed unapproved drugs — it doesn’t always mean the specific product you’re looking at is impure. We show the record and the source so you can judge; we distinguish a proven criminal outcome from a mere charge, and a warning letter from a conviction. We never infer guilt VialGrade cannot source.