Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 9, 2022 | Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 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 |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial... | 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 | 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... |
| 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 | 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 | 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 | 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 | 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... |
| 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/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable,... | 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 | (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 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/ 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 *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 | TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Package... | Lack of sterility assurance. | Class II | Drug Depot, Inc., dba APS Pharmacy |
| 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 | 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 | 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 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 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 | 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 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 | 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 | Hydroxocobalamin 25mg/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 | NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding | 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 | 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 | Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made... | 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 | Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, R... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Biotin 5mg/mL, 5mL-vial, Refrigerate, 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 | Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, T... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compo... | 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 | 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 | 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 | 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 | Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 m... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) ... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Co... | 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.