Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Entecavir Tablets Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed impurity/degradation specifications:Out of Specification result for an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.
Affected Products
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Quantity: 912 30-count bottles
Why Was This Recalled?
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report