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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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 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 Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... 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 AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac... 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 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... 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 Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Jus... 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 PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide ... 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 Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count pa... 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 Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HC... 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 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 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 Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... 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 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... 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 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D... 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 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... CGMP Deviations Class II Edge Pharma, LLC
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 Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... 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 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... 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
Dec 6, 2021 CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... 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.