FDA recall D-0002-2026

Product

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Reason for recall

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Distribution

Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-09-24

Report date

2025-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2026