FDA recall D-0656-2025

Product

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.

Reason for recall

Failed Impurity/Degradation Specifications

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2025-09-04

Report date

2025-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0656-2025