Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Jan 26, 2022 Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufa... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: A... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuati... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE

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.