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 |
|---|---|---|---|---|
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Jan 29, 2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf... | Failed Dissolution Specifications | Class III | Akebia Therapeutics dba Keryx Biopharmaceutials... |
| Jan 7, 2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Dec 9, 2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a... | Failed dissolution specifications: out-of-specification test results observed during the buffer s... | Class II | Biogen MA Inc. |
| Dec 3, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 3, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Nov 25, 2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... | Failed Dissolution Specifications | Class I | Torrent Pharma Inc |
| Nov 24, 2020 | Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by... | Failed Dissolution Specifications; Out of Specification (low) results were obtained. | Class II | Ascend Laboratories LLC |
| Nov 18, 2020 | Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | The Harvard Drug Group |
| Nov 17, 2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... | FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... | Class II | Golden State Medical Supply Inc. |
| Nov 11, 2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Apotex Corp. |
| Oct 30, 2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo... | Failed Dissolution Specifications | Class II | AVKARE Inc. |
| Oct 28, 2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... | Class II | Teva Pharmaceuticals USA |
| Oct 27, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c... | Failed Dissolution Specification | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 27, 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c... | Failed Dissolution Specification | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Aug 24, 2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (6... | Failed Dissolution Specifications | Class II | Strides Inc. |
| Jun 29, 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... | Class II | RemedyRepack Inc. |
| May 27, 2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| May 22, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | The Harvard Drug Group |
| May 19, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... | Class II | American Health Packaging |
| May 15, 2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... | Failed dissolution specifications | Class II | PD-Rx Pharmaceuticals, Inc. |
| May 13, 2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | West-Ward Columbus Inc |
| May 11, 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... | Class III | The Harvard Drug Group |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... | Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... | Class I | Avet Pharmaceuticals, Inc. |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... | Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... | Class I | Avet Pharmaceuticals, Inc. |
| Feb 20, 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... | Failed Dissolution Specifications: Low out of specification dissolution result observed during st... | Class II | Teva Pharmaceuticals USA |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 22, 2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... | Failed Dissolution Specifications: low out of specification results for dissolution testing. | Class III | Ascend Laboratories LLC |
| Jan 20, 2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... | Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... | Class III | Macleods Pharma Usa Inc |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | The Harvard Drug Group |
| Dec 10, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 4, 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... | Failed Dissolution Specifications: Low out of specification results obtained during stability tes... | Class II | American Health Packaging |
| Oct 18, 2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... | Failed Dissolution Specification: Low out of specification dissolution results. | Class II | Mylan Pharmaceuticals Inc. |
| Aug 26, 2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici... | Failed Dissolution Specifications: | Class III | EPI Health, LLC |
| Aug 9, 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Jul 29, 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... | Failed Dissolution Specifications | Class II | Upsher Smith Laboratories, Inc. |
| Jul 24, 2019 | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... | Failed dissolution specifications | Class II | Alvogen, Inc |
| Jul 24, 2019 | Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... | Failed dissolution specifications | Class II | Alvogen, Inc |
| Jul 19, 2019 | Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... | Failed Dissolution Specifications | Class II | Ascend Laboratories LLC |
| Jul 18, 2019 | Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manu... | Failed Dissolution Specifications. | Class II | Ucb, Inc |
| Jul 17, 2019 | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... | Failed Dissolution Specifications | Class II | Macleods Pharma Usa Inc |
| Jul 9, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... | Failed dissolution specifications : failed results at the 3-month stability time point. | Class I | Jubilant Cadista Pharmaceuticals, Inc. |
| May 31, 2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi USA, Inc. |
| May 31, 2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi USA, Inc. |
| Apr 8, 2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... | Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug r... | Class II | American Health Packaging |
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.