Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 10, 2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... | Labeling: Not elsewhere classified. NDC number is incorrect on the container. | Class III | Northwind Pharmaceuticals LLC |
| Nov 4, 2015 | Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 2, 2015 | Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Oct 30, 2015 | Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor ... | Failed Impurities/Degradation Specifications: Out of specifications results for impurities. | Class III | Avantor Performance Materials Inc |
| Oct 29, 2015 | EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx onl... | Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP mono... | Class III | PQ Corporation |
| Oct 26, 2015 | Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Par Pharmaceutical Inc. |
| Oct 26, 2015 | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Par Pharmaceutical Inc. |
| Oct 21, 2015 | Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, ... | Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was foun... | Class III | Breckenridge Pharmaceutical, Inc |
| 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. |
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.