Carvedilol Tablets — Class II drug recall D-0063-2023
Terminated recall by Viatris Inc, reported 2022-11-23, distributed nationwide. Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
| Recall number | D-0063-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2022-10-21 |
| Classified | 2022-11-16 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2023-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,794 bottles |
| NDC | 00378-3634-05 |
| Lot numbers | 3150116 |
| Expiration dates | 2025-02 |
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 for recall
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0063-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.