Browse Drug Recalls
20 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 20 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 20 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 18, 2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 18, 2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jan 26, 2022 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Aug 20, 2021 | Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... | Subpotent | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 19, 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... | Class III | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Nov 6, 2020 | clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man... | Failed Tablet/Capsule Specification | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| May 26, 2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... | Presence of Foreign Substance visually consistent with the silica granules present in the desicca... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Dec 2, 2019 | Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... | Presence of Foreign Substance: Presence of a foreign object in a single tablet. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Sep 4, 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 29, 2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on ... | Class II | Jubilant Cadista Pharmaceuticals, 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. |
| Oct 2, 2018 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 27, 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Oct 30, 2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Jun 13, 2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 11, 2014 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tabl... | Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. | Class II | Jubilant Cadista Pharmaceuticals Inc. |
| Feb 11, 2013 | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Man... | cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practi... | Class II | Jubilant Cadista Pharmaceuticals 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.