Recalls / Class II
Class IID-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.
- Brand name
- Entecavir
- Generic name
- Entecavir
- Active ingredient
- Entecavir
- Route
- Oral
- NDCs
- 68382-920, 68382-921
- FDA application
- ANDA206745
- Affected lot / code info
- Lot#: E409309, Exp 12/31/2026
Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 600 30-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-09-24
- FDA classified
- 2025-10-02
- Posted by FDA
- 2025-10-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.