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.

DateProductReasonClassFirm
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx on... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex co... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx on... 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 Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalatio... 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 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 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 Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Ph... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured b... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate i... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... 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 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each bl... 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 Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic so... 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 Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: San... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sando... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), package... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distribut... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 0409... 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 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 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 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 Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset T... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dos... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Ph... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials... 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 Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 12, 2022 Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... Subpotent Drug: Out of specification for assay. Class III American Health Packaging
Apr 12, 2022 Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), pac... Labeling: Missing label on the vial Class I Mylan Pharmaceuticals Inc
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 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 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 Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... Subpotent Drug: Out of Specification results for Assay Class III Aurobindo Pharma USA Inc.

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.