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 |
|---|---|---|---|---|
| Mar 1, 2019 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... | Failed Dissolution Specifications | Class III | AVKARE Inc. |
| Feb 28, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... | Failed Dissolution Specifications; 9-monthstability timepoint | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Feb 21, 2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... | Failed Dissolution Specifications | Class III | Lannett Company Inc. |
| Feb 19, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... | Failed dissolution specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Jan 31, 2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ... | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Dec 20, 2018 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... | Failed Dissolution Specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Dec 20, 2018 | Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... | Failed Dissolution Specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Dec 19, 2018 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged i... | Failed dissolution specifications | Class II | Teva Pharmaceuticals USA |
| Dec 14, 2018 | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... | Failed Dissolution Specifications. | Class II | Cipla Limited |
| Dec 10, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 22, 2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 19, 2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... | Class II | Teva Pharmaceuticals USA |
| Oct 5, 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... | Class III | Amerigen Pharmaceuticals Inc. |
| Sep 11, 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... | Class II | Torrent Pharma Inc. |
| Aug 7, 2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged l... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Aug 1, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... | Failed Dissolution Specifications: Out of specification result for the dissolution test. | Class II | American Health Packaging |
| Jul 30, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... | Failed Dissolution Specifications | Class II | MAJOR PHARMACEUTICALS |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 17, 2018 | Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... | Failed Dissolution Specification: Low dissolution outside of specifications | Class III | Rhodes Pharmaceuticals, L.P. |
| 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 |
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.