Browse Drug Recalls
1,045 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,045 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 1,045 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... | Class III | Akorn, Inc. |
| Mar 22, 2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg,... | Failed Impurities/Degradation Specifications: Out-of-specification results observed in related su... | Class II | Lupin Pharmaceuticals Inc. |
| Mar 12, 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ... | Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi... | Class II | Akorn Inc |
| Mar 7, 2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... | Class III | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Mar 1, 2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... | Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity... | Class II | American Health Packaging |
| Feb 28, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... | Failed Dissolution Specifications; 9-monthstability timepoint | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Feb 22, 2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... | Class II | Akorn, Inc. |
| Feb 13, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... | Failed Impurities/Degradation Specifications: High out of specification results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Feb 13, 2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... | Failed Degradation/Impurities Specifications: Out of specification related substance results duri... | Class III | Perrigo New York, Inc. |
| Feb 4, 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... | Failed Stability Specification: out of specification results for Sodium Perborate | Class II | Akorn Inc |
| Feb 1, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... | Failed Impurities/Degradation Specifications: Out of specification test results in related substa... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 25, 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... | Class III | Akorn Inc |
| Jan 18, 2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 18, 2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0... | Failed Impurities/Degradation Specifications: Related compound results obtained during routine st... | Class II | Mylan Pharmaceuticals Inc. |
| Dec 20, 2018 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... | Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... | Class III | Akorn Inc |
| Dec 10, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 8, 2018 | INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ... | Failed Stability Specification: out of specification for iron content. | Class II | ALLERGAN |
| Nov 7, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 6, 2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... | Class III | Breckenridge Pharmaceutical, Inc. |
| Nov 6, 2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... | Class III | Takeda Development Center Americas, Inc. |
| Oct 26, 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... | Class III | RemedyRepack Inc. |
| Oct 22, 2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 19, 2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... | Class II | Teva Pharmaceuticals USA |
| Oct 19, 2018 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 19, 2018 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 19, 2018 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 5, 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... | Class III | Amerigen Pharmaceuticals Inc. |
| Oct 5, 2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri... | Class II | LUPIN SOMERSET |
| Oct 3, 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... | Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... | Class III | InvaGen Pharmaceuticals, Inc. |
| Sep 27, 2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2018 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ... | Failed stability specifications - An out of specification result was observed for the test parame... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 20, 2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... | Failed Stability Specifications: Out-of-specification test result for water content obtained duri... | Class II | Teva Pharmaceuticals USA |
| Sep 11, 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... | Class II | Torrent Pharma Inc. |
| Aug 28, 2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... | Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... | Class III | Pfizer Inc. |
| Aug 27, 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 23, 2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... | Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... | Class III | LUPIN SOMERSET |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 3, 2018 | dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distr... | Failed Stability Specifications: separation of product and failure for actives. | Class II | Product Quest Manufacturing LLC |
| Aug 2, 2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... | Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... | Class II | Akorn, Inc. |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Failed Stability Specifications: lot out of specification for elevated water vapor. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... | Class III | Renaissance Lakewood, LLC |
| Jun 29, 2018 | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... | Class II | SCA Pharmaceuticals |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
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.