FDA Drug recall D-0393-2022
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumba…
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumba… by Ascend Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0393-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-12 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
Reason
Failed Dissolution Specifications.
Identifiers
| ndc | 67877-590-30 |
|---|---|
| ndc | 67877-590-60 |
| ndc | 67877-590-01 |
| ndc | 67877-590-05 |
| ndc | 67877-590-10 |
| ndc | 67877-591-30 |
| ndc | 67877-591-60 |
| ndc | 67877-591-01 |
| ndc | 67877-591-05 |
| ndc | 67877-591-10 |
| ndc | 67877-592-30 |
| ndc | 67877-592-60 |
| ndc | 67877-592-01 |
| ndc | 67877-592-05 |
| ndc | 67877-592-10 |
| ndc | 67877-593-30 |
| ndc | 67877-593-60 |
| ndc | 67877-593-01 |
| ndc | 67877-593-05 |
| ndc | 67877-593-10 |
| code_info | Lot #: 21143093, Exp. March 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0393-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.