Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2022 | Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz P... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthc... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 12, 2022 | Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, I... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 11, 2022 | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ... | CGMP deviations: tablets cracking | Class II | Torrent Pharma Inc |
| Apr 7, 2022 | Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manuf... | Failed Impurities/Degradation Specifications: High out of specification results obtained for rela... | Class II | Mylan Pharmaceuticals Inc |
| Apr 6, 2022 | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1)... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 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 | 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 | 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 | 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 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... | Failed Reconstitution time | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.