Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 9, 2022 | T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceut... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharma... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Ph... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Ol... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atro... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympi... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanoba... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pha... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamin... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL ... | 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 | Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dos... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only,... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Ol... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 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 | Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Mangan... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... | 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 Single-Dose Vial... | 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 | 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 | 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 | 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 | 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... |
| 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/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/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged ... | Lack of sterility assurance. | Class II | Drug Depot, Inc., dba APS Pharmacy |
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.