Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Apr 13, 2022 BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx o... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... cGMP deviations: Temperature abuse Class III Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), pac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Maj... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz P... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
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 Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count b... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Phar... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmac... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL)... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, R... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25... 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 13, 2022 Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered i... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 m... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-fiv... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pha... 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 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 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 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 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 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 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 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 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 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-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

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.