Browse Drug Recalls
46 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 46 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 46 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Jan 31, 2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... | cGMP Deviations | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactu... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: ... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manu... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Ma... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila ... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactu... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufa... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufac... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: ... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: C... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufac... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| May 6, 2019 | MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by:... | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Class II | Zydus Pharmaceuticals USA Inc |
| Apr 25, 2019 | Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:... | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... | Class II | Zydus Pharmaceuticals USA Inc |
| Apr 25, 2019 | Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C... | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... | Class II | Zydus Pharmaceuticals USA Inc |
| Apr 22, 2019 | Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by... | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan... | Class III | Zydus Pharmaceuticals USA Inc |
| Nov 20, 2017 | Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count... | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets | Class II | Zydus Pharmaceuticals USA Inc |
| Aug 18, 2017 | Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cad... | Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets | Class II | Zydus Pharmaceuticals USA 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 7, 2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The K... | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 6, 2017 | ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023... | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... | Class II | Zydus Pharmaceuticals USA Inc |
| 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 |
| Aug 3, 2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, ... | Failed Dissolution Specifications: Product did not meet dissolution specification at an intermedi... | Class III | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 6... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| May 9, 2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufac... | Failed impurities/degradation specifications: Out of specification results noticed in related sub... | Class II | Zydus Pharmaceuticals USA Inc |
| Jan 14, 2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manu... | Failed Impurities/Degradation Specifications: Out of specification for a known degradant. | Class III | Zydus Pharmaceuticals USA Inc |
| Dec 23, 2014 | Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthca... | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. | Class II | Zydus Pharmaceuticals USA Inc |
| Nov 26, 2014 | Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured b... | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. | Class II | Zydus Pharmaceuticals USA Inc |
| Oct 1, 2014 | Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manuf... | Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. | Class III | Zydus Pharmaceuticals USA Inc |
| Sep 24, 2014 | BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured... | Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsu... | Class III | Zydus Pharmaceuticals USA Inc |
| Sep 15, 2014 | TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila... | Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. | Class II | Zydus Pharmaceuticals USA Inc |
| Aug 5, 2014 | ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufacture... | Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were notic... | Class II | Zydus Pharmaceuticals USA Inc |
| May 8, 2014 | PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. ... | Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tabl... | Class II | Zydus Pharmaceuticals USA Inc |
| May 13, 2013 | Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufa... | Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who disc... | Class I | Zydus Pharmaceuticals USA Inc |
| Mar 5, 2013 | Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx o... | Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/o... | Class II | Zydus Pharmaceuticals USA Inc |
| Mar 14, 2012 | Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets pe... | Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discover... | 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.