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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

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... 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 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 Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, 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 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 PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnes... 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 Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd.... 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 18, 2022 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... Failed Dissolution Specification: Dissolution results are below specification limits for the acti... Class II Teva Pharmaceuticals USA
Jan 14, 2022 Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only... Failed Impurities/Degradation Specifications Class II Aurobindo Pharma USA 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 12, 2022 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... Failed Dissolution Specifications. Class II Ascend Laboratories, LLC
Jan 11, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, ... Lack of Assurance of Sterility Class II Exela Pharma Sciences LLC
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
Jan 10, 2022 Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA
Jan 7, 2022 Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... Failed Stability Specifications Class II VistaPharm, Inc.
Jan 5, 2022 Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Class II Akorn, Inc.
Dec 31, 2021 MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 31, 2021 Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 31, 2021 Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distrib... Complaint received of foreign matter (metal) embedded in tablet. Class II Rubicon Research Private Limited
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 29, 2021 Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b... Failed Impurities/Degradation Specifications Class II RemedyRepack Inc.
Dec 29, 2021 Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo... Superpotent and Failed Tablet/Capsule Specifications Class II Aurobindo Pharma USA 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 27, 2021 Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bott... Defective Delivery System Class II Padagis US LLC
Dec 21, 2021 Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ... Failed impurities/degradation specifications Class II Ascend Laboratories, LLC
Dec 21, 2021 Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single... Lack of Assurance of Sterility Class II Ideal Specialty Apothecary, Inc. dba Ideal Phar...
Dec 20, 2021 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... Failed Dissolution Specifications Class II American Health Packaging
Dec 16, 2021 Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ... Subpotent Class II Teva Pharmaceuticals USA
Dec 8, 2021 Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl... Defective Container: The notch in the cap that fits into the nozzle of the dropper could break of... Class II Teva Pharmaceuticals USA
Dec 7, 2021 Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distri... Defective Container: Leaking containers. Class II Direct Rx
Dec 6, 2021 Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Prese... Lack of Assurance of Sterility 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 NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter... Class II Organics Corporation of America DBA Ambix Labor...
Dec 6, 2021 Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syrin... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for I... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dro... Lack of Assurance of Sterility. 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

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.