FDA Recall D-0657-2025
Zydus Pharmaceuticals (USA) Inc · Pennington, NJ
Class II Ongoing 252 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0657-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-09-04
- Classified by FDA Center
- 2025-09-18
- FDA published
- 2025-09-24
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Firm location
- Pennington, NJ
Drug identification
- Brand name(s)
- ENTECAVIR
- Generic name(s)
- ENTECAVIR
- Manufacturer(s)
- Zydus Pharmaceuticals USA Inc.
- NDC(s)
68382-920, 68382-921- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.