Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
Jan 24, 2022 Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... 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 Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5... 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 MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dis... 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 DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, package... 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 CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Di... 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 MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... 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 Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 ... 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 CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 t... 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 PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110... 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 PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco I... 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 FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-co... 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 DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenyleph... 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 Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count pac... 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 CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)... 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 Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg)... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, pa... 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 Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in... 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 PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b... 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
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 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... 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
Dec 15, 2021 Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria Class I Taro Pharmaceuticals U.S.A., Inc.
Dec 6, 2021 kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Valisa MFG LLC
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Nov 29, 2021 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... CGMP Deviations: failed stability results, inadequate laboratory investigations, Class II ULTRAtab Laboratories, Inc.
Nov 19, 2021 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... Product Mix-up Class II Ascent Pharmaceuticals, Inc.
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, 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.