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.
Class II · Ongoing
Failed Impurity/Degradation Specifications
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Affected lots / codes — check yours against thisLot E309377, Exp 11/30/2025
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 4440 bottles
- Distribution
- U.S. Nationwide
- Recall initiated
- September 4, 2025
- Classified
- September 18, 2025
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0657-2025%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0657-2025%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →