Drug recall D-0657-2025
Product
Entecavir Tablets, USP, 1 mg, 30 Tablets, 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
Lots and codes
Lot E309377, Exp 11/30/2025
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 4440 bottles
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 4, 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.