Class II · ModerateRecall completed
Carvedilol Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 3150116, Exp 2/2025
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMade in India foreign manufacturer
| Distributed by / for | Viatris Inc |
| NDC | 0378-3634-05 |
Show the full FDA record
| Full product label | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 |
| Recalling firm | Viatris Inc |
| Distribution | Nationwide in the USA |
| Quantity | 2,794 bottles |
| Recall initiated | 2022-10-21 |
| Report date | 2022-11-23 |
| Recall completed | 2023-07-13 |
| Recall number | D-0063-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Canonsburg PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.