Class II · ModerateActive recall
Entecavir
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot E309376; Exp 11/30/2025
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
Failed Impurity/Degradation Specifications
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 byZydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
| Brand name | ENTECAVIR |
| Generic name | ENTECAVIR |
| Active ingredient(s) | ENTECAVIR |
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 |
| NDC | 68382-920-06 |
Show the full FDA record
| Full product label | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | U.S. Nationwide |
| Quantity | 4344 bottles |
| Recall initiated | 2025-09-04 |
| Report date | 2025-09-24 |
| Recall completed | — |
| Recall number | D-0656-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington 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.