Browse Drug Recalls

1,710 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,710 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 1,710 FDA drug recalls, Class III.

Clear
DateProductReasonClassFirm
Oct 21, 2015 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 20, 2015 Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... Labeling: Incorrect or Missing Lot AND/OR Exp Date. Class III Teva Pharmaceutical Industries
Oct 19, 2015 HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 13, 2015 Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H... Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a... Class III Rx PAK
Oct 1, 2015 Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Oct 1, 2015 Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Sep 29, 2015 Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,... Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p... Class III Hospira Inc.
Sep 28, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un... Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class III Perrigo Company PLC
Sep 25, 2015 FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Sep 25, 2015 FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Sep 16, 2015 UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 16, 2015 UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribu... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 10, 2015 ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays... Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. Class III EMD Serono, Inc.
Sep 9, 2015 Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or I... Subpotent Drug Class III Ferring Pharmaceuticals Inc
Aug 31, 2015 ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... Falied pH specification Class III Oasis Medical, Inc.
Aug 21, 2015 Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ... Defective Container: Product missing safety seal around the neck of the bottle. The product labe... Class III Akorn, Inc.
Aug 21, 2015 Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx o... Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the... Class III Silarx Pharmaceutical, Inc.
Aug 20, 2015 RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lak... Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known im... Class III Akorn, 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 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/20 mg, Packaged i... 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, 5 mg/20 mg, Packaged in... Subpotent Drug: Subpotent atorvastatin. Class III Dr. Reddy's Laboratories, Inc.
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 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 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 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 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.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATIN... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, 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.