Why it was recalled
Failed Impurity/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot E309376; Exp 11/30/2025
Where it was sold
U.S. Nationwide
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-0656-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 4, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 4344 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0656-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97556
- Address
- 73 Route 31 N
- Code information
- Lot E309376; Exp 11/30/2025
- Postal code
- 08534-3601
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0656-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 4344 bottles
- Reason for recall
- Failed Impurity/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 4, 2025
- Center classification date
- Sep 18, 2025