FDAFDA · Food and drugs·Recall number D-0002-2026
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.
Published October 8, 2025 · Recall initiated: September 24, 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:Out of Specification result for an individual organic impurity
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ENTECAVIR
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot#: E409309, Exp 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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