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Vehicle Safety

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

Consumer Safety

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

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Feb 10, 2017 CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / P... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 49... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arb... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETIN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Jan 27, 2017 MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxid... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMI... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) t... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Mad... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 ... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottl... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per ca... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 l... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (3... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Dec 15, 2016 Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell... CGMP Deviations Class II Gentell, Inc
Dec 15, 2016 Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-... CGMP Deviations Class II Gentell, Inc
Dec 14, 2016 Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... CGMP Deviations Class II Apotex Corp.
Dec 14, 2016 Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... CGMP Deviations Class II Apotex Corp.
Dec 12, 2016 Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016 Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016 Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016 VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Nov 18, 2016 Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Nov 18, 2016 CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Nov 18, 2016 CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Oct 28, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-7... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 28, 2016 Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-7... CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... Class II Nationwide Laboratories, LLC
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc

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.