Safety Alert: Class II: Failed Impurity/Degradation Specifications
healthClass IIRecalled on Sep 24, 2025
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
🔢 4344 bottles
Sold At: Zydus Pharmaceuticals (USA) Inc(U.S. Nationwide)
Recall #: FDA-DRUG-D-0656-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot E309376; Exp 11/30/2025
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Summary
Failed Impurity/Degradation Specifications
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Zydus Pharmaceuticals (USA) Inc for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.