Drug 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
Lots and codes
Lot#: E409309, Exp 12/31/2026
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 600 30-count bottles
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 24, 2025
Related products
- Entecavir – drug information
- NDC 68382-921 Entecavir · Entecavir 1 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-920 Entecavir · Entecavir .5 mg/1 · Zydus Pharmaceuticals USA Inc.