Class II · ModerateActive recall
Carvedilol
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26
Where it was soldU.S. Nationwide
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
CGMP Deviations
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 byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 foreign manufacturer
| Brand name | CARVEDILOL |
| Generic name | CARVEDILOL |
| Active ingredient(s) | CARVEDILOL |
| Distributed by / for | Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 |
| NDC | 68462-164-05 |
Show the full FDA record
| Full product label | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05. |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall initiated | 2025-03-13 |
| Report date | 2025-04-16 |
| Recall completed | — |
| Recall number | D-0336-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah NJ 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.