Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Jan 26, 2022 ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured b... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
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 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 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... 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 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 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... 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 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 24, 2022 Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, G... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count pac... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco I... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Di... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count pac... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-coun... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenyleph... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnes... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dis... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 capl... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bott... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by Z... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afas... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, package... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... cGMP deviations Class II Ultra Seal Corporation

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.