Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Product description
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Lot numbers, UPCs & expiration codes
Lot#: E409308, Exp 12/31/2026
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0001-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 24, 2025
- FDA report date
- Oct 8, 2025
- Quantity
- 912 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0001-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97684
- Address
- 73 Route 31 N
- Code information
- Lot#: E409308, Exp 12/31/2026
- Postal code
- 08534-3601
- Report date
- Oct 8, 2025
- Product type
- Drugs
- Recall number
- D-0001-2026
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 912 30-count bottles
- Reason for recall
- Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Sep 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 2, 2025