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.

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DateProductReasonClassFirm
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.