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
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... Class I Junp Hydration LLC
Jan 26, 2022 Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Conta... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... 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 Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... 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 APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... 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 Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... 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 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... 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 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... 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 Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labo... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
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 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 24, 2022 Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... 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 CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorp... 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 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... 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 Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... 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 Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... 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 Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... 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 EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by Z... 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 Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... 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.