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 |
|---|---|---|---|---|
| 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. |
| Jun 6, 2014 | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop... | Stability Data Does Not Support Expiry | Class III | Estee Lauder Inc |
| May 28, 2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... | Failed Stability Specification; out of specification result for particle size distribution during... | Class III | Novartis Pharmaceuticals Corp. |
| 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 1, 2014 | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... | Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... | Class II | Boehringer Ingelheim Roxane Inc |
| May 1, 2014 | Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Ba... | Failed Impurities/Degradation Specifications: this product is being recalled due to an out of spe... | Class II | Teva Pharmaceuticals USA |
| 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 7, 2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... | Class II | Teva Pharmaceuticals USA |
| Apr 7, 2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... | Class II | Teva Pharmaceuticals USA |
| Apr 1, 2014 | triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP... | Failed Impurities/Degradation Specifications: This recall is due to out of specification for impu... | Class II | Teva Pharmaceuticals USA |
| Apr 1, 2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 F... | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone... | Class III | Genesis Pharmaceutical, Inc. |
| Apr 1, 2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... | Class II | Hi-Tech Pharmacal Co., Inc. |
| 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 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 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... | Class III | Apotex Inc. |
| Feb 11, 2014 | QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy... | Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point | Class III | Teva Pharmaceuticals USA |
| Feb 10, 2014 | Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx... | Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than No... | Class III | Pinnacle Biologics Inc |
| Jan 27, 2014 | Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit... | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 27, 2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute... | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 14, 2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distri... | Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets,... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 3, 2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 20, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Class II | Watson Laboratories, Inc.-(Actavis) - Florida |
| Dec 16, 2013 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... | Failed Stability Testing: This product is below specification for preservative content. | Class III | Bracco Diagnostics Inc |
| Dec 13, 2013 | Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... | Failed Dissolution Specification; 12-Month stability interval. | Class II | Dr. Reddy's Laboratories, Inc. |
| 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 |
| Nov 22, 2013 | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun C... | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... | Class II | Physicians Total Care, Inc. |
| Nov 15, 2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. | Class III | Actavis Inc |
| Nov 14, 2013 | Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L... | Failed Stability Specifications: this product is below specification for preservative content. | Class III | Teva Pharmaceuticals USA, Inc. |
| Nov 13, 2013 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, ... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals Inc |
| Nov 13, 2013 | Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, pa... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals Inc |
| Nov 13, 2013 | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) ext... | Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... | Class III | Forest Pharmaceuticals Inc |
| Nov 7, 2013 | Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ... | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... | Class II | West-Ward Pharmaceutical Corp. |
| Nov 6, 2013 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... | Class II | Actavis Elizabeth LLC |
| Nov 6, 2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... | Class III | Sandoz Inc |
| Nov 4, 2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... | Failed Dissolution Specification; 8 hr stability timepoint | Class III | Pfizer Inc. |
| Oct 28, 2013 | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... | Failed Stability Specification; product viscosity and or pH are below specification. | Class III | Hi-Tech Pharmacal Co., Inc. |
| Oct 15, 2013 | Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... | Defective Container: A lidding deformity allowed for the product to have out of specification res... | Class II | VistaPharm, Inc. |
| Oct 7, 2013 | Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules ... | Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 m... | Class II | Amedra Pharmaceuticals LLC |
| Sep 17, 2013 | Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lu... | Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... | Class II | Lupin Pharmaceuticals Inc. |
| Sep 17, 2013 | Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lup... | Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... | Class II | Lupin Pharmaceuticals Inc. |
| Sep 11, 2013 | Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J... | Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril... | Class II | Janssen Pharmaceuticals, Inc. |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Jul 19, 2013 | Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... | Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... | Class III | Bracco Diagnostics Inc |
| Jul 18, 2013 | ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... | Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... | Class III | Vi-Jon, Inc. |
| Jul 2, 2013 | Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured a... | Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out ... | Class II | Core Pharma 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.