Recalls / Class II
Class IID-0656-2025
Product
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
- Brand name
- Entecavir
- Generic name
- Entecavir
- Active ingredient
- Entecavir
- Route
- Oral
- NDCs
- 68382-920, 68382-921
- FDA application
- ANDA206745
- Affected lot / code info
- Lot E309376; Exp 11/30/2025
Why it was recalled
Failed Impurity/Degradation Specifications
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 4344 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-09-04
- FDA classified
- 2025-09-18
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0656-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.