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healthClass IIRecalled on Sep 24, 2025

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

🔢 4440 bottles

Sold At: Zydus Pharmaceuticals (USA) Inc(U.S. Nationwide)

Recall #: FDA-DRUG-D-0657-2025

Source: FDA-ENFORCEMENT

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

Product Identification

Lot/Batch Codes:
Lot E309377, 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.