FDAFDA · Food and drugs·Recall number D-0656-2025
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.
Published September 24, 2025 · Recall initiated: September 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specifications
What to do
Voluntary: Firm initiated
Recall details
- Brand
- ENTECAVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot E309376; Exp 11/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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