Browse Drug Recalls
412 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 412 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 412 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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. |
| Nov 27, 2013 | Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle,... | Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit ... | Class II | Wockhardt Usa 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 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 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), 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 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. |
| Nov 4, 2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... | Class III | Greenstone Llc |
| 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 16, 2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, pac... | Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. | Class III | Osmotica Pharmaceutical Corp |
| Sep 4, 2013 | Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By:... | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... | Class II | Greenstone Llc |
| Sep 4, 2013 | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ... | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... | Class II | Pfizer Us Pharmaceutical Group |
| Sep 4, 2013 | Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By:... | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... | Class II | Greenstone Llc |
| Aug 21, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... | Class III | Actavis South Atlantic LLC |
| Aug 17, 2013 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne... | Failed dissolution specifications; 18 month CRT | Class II | Amneal Pharmaceuticals of New York, LLC. |
| Jul 31, 2013 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... | Class III | Actavis Inc |
| Jun 18, 2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun... | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... | Class II | Teva Pharmaceuticals USA, Inc. |
| Jun 18, 2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun... | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... | Class II | Teva Pharmaceuticals USA, Inc. |
| Jun 18, 2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun... | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... | Class II | Teva Pharmaceuticals USA, Inc. |
| May 31, 2013 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... | Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... | Class III | Pfizer Inc. |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.... | Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxy... | Class III | Pfizer Inc. |
| May 28, 2013 | Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin... | Failed Dissolution Specification; during stability testing | Class II | Teva Pharmaceuticals USA, Inc. |
| May 15, 2013 | Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... | Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 22, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... | Class III | Actavis South Atlantic LLC |
| Feb 13, 2013 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceed... | Class III | Actavis Elizabeth LLC |
| Feb 4, 2013 | buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... | Failed Stability Specifications; out of specification results at the 9 month stability time point... | Class III | American Health Packaging |
| Jan 4, 2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. | Class III | Actavis Pharmaceuticals |
| Dec 18, 2012 | Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 36... | Failed Dissolution Specification: Out of a specification result occurred during the 3-month stabi... | Class II | Watson Pharmaceuticals |
| Dec 4, 2012 | Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... | Failed Dissolution Specifications; 36 month stability timepoint | Class II | West-ward Pharmaceutical Corp. |
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.