FDA-Drug2025-09-24Class II
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.
Zydus Pharmaceuticals (USA) Inc
Hazard
Failed Impurity/Degradation Specifications
Sold states
U.S. Nationwide
Affected count
4344 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0656-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief