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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 10, 2018 Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II Hetero Labs, Ltd. - Unit III
Jan 9, 2018 Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Dec 15, 2017 Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... Class III Akorn Inc
Nov 28, 2017 Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... Class II EAI-JR286 INC
Nov 20, 2017 Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G... CGMP Deviations: Market complaints related to "gritty texture". Class II Glenmark Pharmaceuticals Inc., USA
Oct 25, 2017 Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Sep 27, 2017 Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), ... CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unk... Class II United Pharmacy
Sep 14, 2017 Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... Class II Medisca, Inc.
Sep 11, 2017 TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg... CGMP Deviations Class II United Therapeutics Corp.
Sep 5, 2017 Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Steri... Lack of Assurance of Sterility and cGMP Deviations Class II Simple Diagnostics, Inc.
Aug 30, 2017 Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Mid Valley Pharmaceutical
Aug 30, 2017 Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Mid Valley Pharmaceutical
Jul 12, 2017 Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... CGMP Deviations Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jul 12, 2017 Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... CGMP Deviations: Firm failed to control impurity for color change at the API stage. Class III Pfizer Inc.
Jun 6, 2017 NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... Class II Bausch & Lomb, Inc.
Jun 1, 2017 Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis... CGMP Deviations Class II Xttrium Laboratories Inc
Jun 1, 2017 Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... Class II American Pharmaceutical Ingredients LLC
May 26, 2017 Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500... CGMP Deviations: Lack of quality assurance at the API manufacturer. Class II American Pharmaceutical Ingredients LLC
May 2, 2017 Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... CGMP Deviations Class III Lupin Pharmaceuticals Inc.
Apr 19, 2017 Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count an... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count,... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II Gentell, Inc
Apr 19, 2017 Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 17, 2017 ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:... cGMP Deviations; lack of quality assurance. Class II American Pharmaceutical Ingredients LLC
Apr 17, 2017 EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, table... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 17, 2017 EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,10... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 13, 2017 Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Pl... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg con... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 6, 2017 Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Apr 6, 2017 Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Apr 3, 2017 ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 gram... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-08... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Mar 24, 2017 Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufacture... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, M... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compoundin... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.

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.