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
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Jan 3, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... Failed Dissolution Specifications: Low out of specification results for dissolution during annual... Class II AVKARE Inc.
Nov 21, 2017 Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... Failed Dissolution Specification Class III Lupin Pharmaceuticals Inc.
Nov 9, 2017 Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distrib... Failed Dissolution Specifications. Class II Mayne Pharma Inc
Oct 25, 2017 Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... Class II Teva Pharmaceuticals USA
Oct 17, 2017 Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: Low out of specification results for dissolution. Class III Teva Pharmaceuticals USA
Aug 4, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... Failed Dissolution Specifications Class III Pfizer Inc.
Aug 4, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... Failed Dissolution Specifications Class III Pfizer Inc.
Jun 22, 2017 Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... Class III Lupin Pharmaceuticals Inc.
May 31, 2017 Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... Class I Teva Pharmaceuticals
May 24, 2017 Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
May 24, 2017 PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
Mar 15, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... Failed Dissolution Specifications; 9 month long term stability Class II Zydus Pharmaceuticals USA Inc
Mar 13, 2017 Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... Failed Dissolution Specifications Class II Akorn Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Feb 17, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications: low out of specification dissolution results found during stab... Class III Teva Pharmaceuticals USA
Feb 15, 2017 Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 10, 2017 Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o... Failed Dissolution Specifications Class II Sandoz Inc
Feb 7, 2017 Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsi... Failed Dissolution Specifications Class II RemedyRepack Inc.
Feb 3, 2017 GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21... Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Amerisource Health Services
Jan 30, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... Class II Actavis Inc
Jan 12, 2017 Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... Failed Dissolution Specifications Class II Sun Pharmaceutical Industries, Inc.
Jan 5, 2017 Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Dec 28, 2016 Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 22, 2016 Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... Failed dissolution specification: recalled due to an out of specification dissolution result of 4... Class II Sandoz Incorporated
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Dec 12, 2016 Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65... Failed Dissolution Specifications Class II Amneal Pharmaceuticals LLC
Dec 1, 2016 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications Class III Teva Pharmaceuticals USA
Nov 2, 2016 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3... Failed Dissolution Specifications; 6 month time point Class III Zydus Pharmaceuticals USA Inc
Oct 27, 2016 Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... Class III Amerisource Health Services
Oct 3, 2016 Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... Class II West-Ward Pharmaceuticals 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.