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.

Clear
DateProductReasonClassFirm
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.