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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Aug 17, 2015 Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured b... Lack of Assurance of Sterility: Failed preservative effectiveness testing. Class II Bausch & Lomb, Inc.
Aug 17, 2015 Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 cou... Failed Stability Specifications: product may not meet specification limit for assay test. Class II Apotex Inc.
Aug 14, 2015 Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contain... Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin ... Class II Merck Sharp & Dohme, Wilson Facility
Aug 13, 2015 Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count ... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count ... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf box... Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece ... Class II Safecor Health, LLC
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured fo... Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged i... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count B... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count B... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
Aug 13, 2015 Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 11, 2015 METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured b... Presence of Foreign Substance: Presence of hair. Class III Golden State Medical Supply Inc.
Aug 6, 2015 LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged ... Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. Class I Blue Square Market, Inc.
Aug 6, 2015 DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isop... Chemical contamination: Product may be contaminated with a toxic compound. Class II 3M Company - Health Care Business
Aug 6, 2015 KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 str... Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. Class I Blue Square Market, Inc.
Aug 5, 2015 Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd ... Failed Impurities/Degradation Specifications: Out of specification results for impurities testing... Class III Taro Pharmaceuticals, Inc.
Aug 3, 2015 Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Jul 30, 2015 Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactur... Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of ... Class II Unichem Pharmaceuticals Usa Inc
Jul 29, 2015 Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jul 29, 2015 Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jul 29, 2015 Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500... Failed Dissolution Specifications Class II Vintage Pharmaceuticals LLC dba Qualitest Pharm...
Jul 28, 2015 Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Equaline Original Prescription Strength, loratadine orally disintegrating tab... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packag... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATIN... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-cou... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Dis... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablet... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule... Failed Dissolution Specifications: Product is being recalled due to out of specification (above s... Class III Novartis Pharmaceuticals Corp.
Jul 28, 2015 Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets pe... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Oral... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; sin... Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) ... Class III Fresenius Kabi USA, LLC
Jul 28, 2015 Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, D... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged i... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 27, 2015 Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3... Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. Class II Noven 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.