Zydus Pharmaceuticals recalled 912 bottles of Entecavir Tablets on September 24, 2025, due to failed impurity specifications. The recall affects 30-count bottles of 0.5 mg tablets Distributed nationwide in the USA.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
The recalled product is Entecavir Tablets, USP, 0.5 mg, sold in 30-count bottles. The lot number is E409308 with an expiration date of December 31, 2026.
The recall stems from an out-of-specification result for an individual organic impurity. This could pose serious health risks to consumers.
No injuries or adverse events have been reported at this time. The FDA classified this recall as Class II due to the potential health risk.
Consumers should stop using Entecavir Tablets immediately. Contact Zydus Pharmaceuticals or your healthcare provider for guidance.
For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX. Visit their website or the FDA link for further details.
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