Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pe... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| 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 | Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alco... | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Class II | Lula Holdings L.L.C. |
| 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 | Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class I | Cardinal Health Inc. |
| Apr 5, 2022 | Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose P... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| Apr 4, 2022 | QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . A... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Pa... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atro... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . A... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Mul... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 1... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Mult... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atro... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropi... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharma... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... | Failed Reconstitution time | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Mu... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmac... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Steril... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Hand Sanitizer LLC |
| Apr 4, 2022 | Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, R... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dos... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Ha... | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Class II | Beak & Skiff Cider Mill, Inc. |
| Apr 4, 2022 | T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Pa... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 1, 2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 1, 2022 | CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered... | Marketed Without an Approved NDA/ANDA | Class II | Wellness BioSciences |
| Apr 1, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 1, 2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... | Class III | The Ritedose Corporation |
| Apr 1, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
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.