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.
Other recalls by Viatris
- Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06…
FDA Drug · Class II · 2026-04-15 · Viatris - Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505…
FDA Drug · Class II · 2025-01-22 · Viatris - Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
FDA Drug · Class II · 2025-01-22 · Viatris - Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10),…
FDA Drug · Class II · 2024-12-18 · Viatris - Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10),…
FDA Drug · Class II · 2024-12-18 · Viatris
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.