FDA Drug recall D-0063-2023
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc by Viatris, citing failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0063-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-21 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Reason
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Identifiers
| code_info | Lot #: 3150116, Exp 2/2025 |
|---|
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-0063-2023%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.