Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 | 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 | 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 24, 2015 | Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipi... | Failed Dissolution Specifications | Class III | Shionogi Inc. |
| Jul 21, 2015 | Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bott... | Failed Dissolution Specification: One lot of product did not meet the first stage dissolution spe... | Class III | Apotex Inc. |
| Jul 21, 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC ... | Failed impurities/Degradation specifications: out of specification results for individual unknown... | Class III | PD-Rx Pharmaceuticals, Inc. |
| Jul 20, 2015 | ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for... | Failed Tablet/Capsule Specifications; report of oversized and discolored tablets | Class III | Qualitest Pharmaceuticals |
| Jul 17, 2015 | buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-... | Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it... | Class III | Sun Pharma Global Fze |
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.