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Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Dec 31, 2014 Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... Class II Valeant Pharmaceuticals North America LLC
Dec 30, 2014 Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistami... Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Class II Taro Pharmaceuticals U.S.A., Inc.
Dec 26, 2014 Aztreonam 1 gram in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Gentamicin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 L-cysteine various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefepime various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Tobramycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Diphenhydramine 50 mg/ml vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Dehydrated alcohol vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Linezolid various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Immune globulin g human various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Levofloxacin various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Dopamine various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefazolin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Liposomal Amphotericin B 130 mg in dextrose bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Magnesium sulfate various strengths in sodium chloride Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Milrinone various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Vancomycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Tigecycline various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Deferoxamine various strengths in normal saline Lack of sterility assurance. Class III Walgreens Infusion Services
Dec 26, 2014 Dobutamine various strengths in dextrose Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Folic acid 1 mg/ 0.2 ml pre-drawn syringes Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefoxitin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Imipenem/ cilastatin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Thiamine 100 mg/ ml vials Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Meropenem various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Amikacin various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Daptomycin various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ranitidine various strengths in syringes Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Cefuroxime various strengths in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ertapenem various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Total parenteral nutrition various strengths Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Caspofungin various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Piperacillin/ tazobactam various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ceftazidime various strength in normal saline bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Nafcillin various strengths in sterile water for injection bags Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Ceftriaxone various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 26, 2014 Acyclovir various strengths in normal saline Lack of sterility assurance. Class II Walgreens Infusion Services
Dec 23, 2014 Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthca... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II Zydus Pharmaceuticals USA Inc
Dec 23, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single pati... Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the n... Class II Hospira Inc.
Dec 23, 2014 Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRA... Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Class II Baxter Healthcare Corp.
Dec 22, 2014 ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL,... Failed Impurities/Degradation Specifications: High out of specification results for the known imp... Class III Qualitest Pharmaceuticals
Dec 22, 2014 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira... Lack of Assurance of Sterility: The product has the potential for solution to leak at the adminis... Class II Hospira Inc.
Dec 19, 2014 B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutri... Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used f... Class II Bethel Nutritional Consulting, Inc
Dec 19, 2014 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tub... Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number a... Class III 3M Company/3m Espe Dental Products
Dec 19, 2014 SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutra... Class I Bethel Nutritional Consulting, Inc
Dec 17, 2014 Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g,... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dex... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, 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.