Zydus Pharmaceuticals recalled 4,344 bottles of Entecavir Tablets on September 4, 2025. The recall stems from failed impurity and degradation specifications. Consumers should stop using the product immediately.
Failed Impurity/Degradation Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
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The recalled product is Entecavir Tablets, USP, 0.5 mg, packaged in bottles of 30 tablets. The affected lot number is E309376, with an expiration date of November 30, 2025. These tablets were distributed nationwide across the United States.
The recall is classified as Class II due to failed impurity and degradation specifications. This means the product may cause temporary or medically reversible adverse health consequences.
There have been no reported injuries or incidents associated with the use of these tablets at this time.
Consumers and healthcare providers should stop using Entecavir Tablets immediately. For guidance, contact Zydus Pharmaceuticals (USA) Inc. or consult a healthcare provider.
For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX or visit their website at www.zydususa.com.
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