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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 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 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15... Defective Container: Leakage of unit dose cups that may occur at the seal. 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.
Jan 13, 2017 Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... Failed Stability Specifications: confirmed out of specification results obtained during refrigera... Class II AbbVie Inc.
Jan 12, 2017 Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... Failed Dissolution Specifications Class II Sun Pharmaceutical Industries, Inc.
Jan 9, 2017 Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr... Defective Container: Product complaints received of defect in the seal of the Docetaxel injection... Class II Dr. Reddy's Laboratories, Inc.
Jan 5, 2017 Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, R... Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet ident... Class II Sun Pharmaceutical Industries, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only,... Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of... Class II L. Perrigo Company
Dec 28, 2016 Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 22, 2016 Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratori... Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Class II Roxane Laboratories, Inc.
Dec 22, 2016 Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottle... Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted caps... Class II Aurobindo Pharma USA Inc
Dec 22, 2016 Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... Failed dissolution specification: recalled due to an out of specification dissolution result of 4... Class II Sandoz Incorporated
Dec 21, 2016 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... Subpotency: due to a low, out of specification test result for assay during stability testing. Class II Teva Pharmaceuticals USA
Dec 20, 2016 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-... Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin... Class II Mylan LLC.
Dec 20, 2016 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-... Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin... Class II Mylan LLC.
Dec 20, 2016 Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceutical... Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin... Class II Mylan LLC.
Dec 20, 2016 Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord... Failed tablet/capsule specification: missing break line on the 5mg tablet. Class II Accord Healthcare, Inc.
Dec 20, 2016 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-... Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin... Class II Mylan LLC.
Dec 16, 2016 MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c... Failed Impurities/Degradation Specifications Class II Fresenius Kabi USA, LLC
Dec 15, 2016 AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p... Lack of Assurance of Sterility: Potential cracks in glass vials Class II Amgen, 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 15, 2016 Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bot... Lack of Sterility Assurance Class II Meta Pharmacy Services
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 Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65... Failed Dissolution Specifications Class II Amneal Pharmaceuticals LLC
Dec 6, 2016 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on... Discoloration: there were customer reports of yellow discolored solution. The yellow coloration i... Class II Baxter Healthcare Corporation
Dec 6, 2016 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class II Baxter Healthcare Corporation
Nov 18, 2016 Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
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.
Nov 18, 2016 Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company

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.