Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
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 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... 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 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 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 Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... 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 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 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 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... 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 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 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
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 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 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 Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... 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 24, 2022 MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afas... 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 Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... 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 Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-co... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count pa... 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 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PEPTIME Energy (caffeine 300mg) 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 PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b... 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 Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin ... 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 Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Jus... 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 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... 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 Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... 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

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.