Zydus Pharmaceuticals recalled 4,440 bottles of Entecavir Tablets on September 4, 2025. The recall follows failure to meet impurity and degradation specifications. Consumers should stop using the affected tablets immediately and contact their healthcare provider.
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 recall affects Entecavir Tablets, USP, 1 mg, in 30-tablet bottles. The affected lot number is E309377, with an expiration date of November 30, 2025. The product was distributed nationwide in the United States.
The recall is due to failure to meet impurity and degradation specifications. This could potentially compromise the quality and efficacy of the medication.
There are no reported incidents of injury or adverse effects associated with this recall. The recall is conducted as a precautionary measure.
Stop using the recalled Entecavir Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc. or your healthcare provider for guidance and further information.
For additional information, consumers can contact Zydus Pharmaceuticals at 1-XXX-XXX-XXXX or visit their website.
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