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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,220 FDA drug recalls.

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DateProductReasonClassFirm
May 6, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... Lack of assurance of sterility Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 6, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... Lack of assurance of sterility Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 6, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose... Lack of assurance of sterility Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 6, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... Lack of assurance of sterility Class II SUN PHARMACEUTICAL INDUSTRIES INC
Apr 5, 2022 Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio ... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenv... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, F... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only,... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Apr 5, 2022 BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Green... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II North American Custom Laboratories, LLC dba Far...
Mar 23, 2022 TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Package... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dos... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, F... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable,... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 14, 2022 PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 7, 2022 BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Re... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tai... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tail... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperat... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Com... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, R... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-via... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Mad... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Tem... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made C... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperatur... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor M... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tai... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temp... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compoun... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.