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 24, 2022 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylep... 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 CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium ... 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 CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-coun... 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 REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... 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 AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac... 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 Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-co... 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 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 CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Di... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd.... 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 Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HC... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (aceta... 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 Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 ... 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 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... 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 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... 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 MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... cGMP deviations Class II Ultra Seal Corporation
Jan 21, 2022 Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) top... cGMP deficiencies Class II Mylan Pharmaceuticals Inc
Jan 14, 2022 Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,... CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. Class II Mayne Pharma Inc
Jan 11, 2022 Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The L... cGMP deviations Class II Pharmasol Corporation
Jan 10, 2022 Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... CGMP Deviations Class II Ingenus Pharmaceuticals Llc
Dec 30, 2021 Metformin 750 mg Extended Release NDC # 70518-2920-00 CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II RemedyRepack Inc.
Dec 27, 2021 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II VIONA PHARMACEUTICALS INC
Dec 6, 2021 Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC

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.