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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

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

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.

Clear
DateProductReasonClassFirm
Jul 2, 2019 Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... Class II Lupin Pharmaceuticals Inc.
Jul 2, 2019 Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Pa... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 63463... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram,... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Steri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pha... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointme... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aq... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jun 26, 2019 PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pha... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 m... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Phar... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associat... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx on... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, Firs... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)1... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Assoc... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only,... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, F... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 24, 2019 Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To... Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... Class II H J Harkins Company Inc dba Pharma Pac
Jun 24, 2019 Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren... Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... Class II H J Harkins Company Inc dba Pharma Pac
Jun 21, 2019 TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural 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.