Browse Drug Recalls
392 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 392 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 392 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 21, 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... | Failed Dissolution Specifications: low test results at the 18 month time-point | Class II | Teva North America |
| Dec 2, 2015 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc. |
| Sep 25, 2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. | Class II | Actavis Laboratories, FL, Inc. |
| Sep 4, 2015 | Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distr... | Failed Dissolution Specifications: Failed 24 month dissolution testing. | Class II | Valeant Pharmaceuticals North America LLC |
| 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 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 | 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 24, 2015 | Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipi... | Failed Dissolution Specifications | Class III | Shionogi Inc. |
| Jul 24, 2015 | univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured... | Failed Dissolution Testing: Failed 24 month dissolution testing. | Class II | Ucb, 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 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 |
| Jul 13, 2015 | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch,... | Failed dissolution specifications | Class III | Purdue Pharma L.P. |
| Jun 30, 2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9... | Failed Dissolution Specifications | Class III | GlaxoSmithkline Consmer Healthcare |
| Jun 30, 2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu... | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob... | Class II | Mylan Pharmaceuticals Inc |
| Jun 18, 2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... | Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ... | Class III | Qualitest Pharmaceuticals |
| May 22, 2015 | Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 25... | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2015 | Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, R... | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Class II | Dr. Reddy's Laboratories, Inc. |
| May 20, 2015 | Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only,... | Failed Dissolution Specifications: Low out of specification dissolution results. | Class II | Mylan Lab Inc |
| May 11, 2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: OOS result during stability testing | Class II | Teva Pharmaceuticals USA |
| Apr 21, 2015 | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, ... | Failed Dissolution Specification; 6 month time point | Class II | Alvogen, Inc |
| Apr 17, 2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... | Class II | Valeant Pharmaceuticals North America LLC |
| Mar 17, 2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Class II | Akorn, Inc. |
| Mar 17, 2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Class II | Akorn, Inc. |
| Mar 17, 2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL... | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Class II | Akorn, Inc. |
| Mar 2, 2015 | Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx O... | Failed dissolution specifications | Class II | American Health Packaging |
| Feb 10, 2015 | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... | Failed Dissolution Specifications | Class II | Actavis Elizabeth LLC |
| Jan 21, 2015 | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Ma... | Failed Dissolution Specifications: 6 month time point. | Class II | Sun Pharma Global Fze |
| Nov 19, 2014 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... | Class II | American Health Packaging |
| Oct 22, 2014 | Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... | Class II | Prometheus Laboratories Inc. |
| Sep 26, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/cart... | Failed Dissolution Specification; at the 6-month stability time point | Class II | Forest Pharmaceuticals Inc |
| Sep 26, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles... | Failed Dissolution Specifications; 12 month stability time point | Class II | Sun Pharma Global Inc. |
| Sep 15, 2014 | Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pai... | Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and disso... | Class II | American Family Pharmacy, LLC |
| Sep 15, 2014 | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ... | Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso... | Class II | Astellas Pharma US Inc |
| Aug 19, 2014 | Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ... | Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te... | Class III | Perrigo Holland Inc |
| Jul 24, 2014 | Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-c... | Failed Dissolution Specifications: Dissolution failures found during testing of control samples a... | Class II | Wockhardt Usa Inc. |
| Jul 11, 2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... | Class III | Sandoz Inc |
| Jun 19, 2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... | Failed Dissolution Specification; at the 12 month time interval. | Class III | Mckesson Packaging Services |
| Jun 19, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bott... | Failed Dissolution Specifications: Drug failed stage III dissolution testing. | Class II | Forest Pharmaceuticals Inc |
| Jun 12, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged... | Failed Dissolution Specifications: Stability results found the product did not meet the drug diss... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| May 23, 2014 | Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-cou... | Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 20, 2014 | Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... | Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti... | Class II | West-Ward Pharmaceutical Corp. |
| May 12, 2014 | Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed ... | Failed Dissolution Specifications: One lot of product is being voluntarily recalled because disso... | Class II | Forest Pharmaceuticals Inc |
| Apr 17, 2014 | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... | Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... | Class III | Wockhardt Usa Inc. |
| Apr 10, 2014 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle,... | Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. | Class II | Wockhardt Usa Inc. |
| Apr 1, 2014 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, R... | Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. | Class II | Wockhardt Usa Inc. |
| Mar 20, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... | Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| Mar 20, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... | Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| Mar 3, 2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | Class III | McKesson Packaging Services |
| Feb 4, 2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... | Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. | Class II | Actavis Elizabeth LLC |
| Dec 13, 2013 | Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufac... | Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP... | Class II | Corepharma 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.