Zydus Pharmaceuticals recalled 600 bottles of Entecavir Tablets on September 24, 2025. The recall follows a failed impurity specification that poses health risks. Consumers should stop using the product immediately and contact healthcare providers for guidance.
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
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The recalled product is Entecavir Tablets, USP, 1 mg, in 30-count bottles. It was manufactured by Zydus Lifesciences Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc. Lot number is E409309 with an expiration date of December 31, 2026.
The recall involves tablets that failed to meet impurity and degradation specifications. The affected tablets may contain an unapproved organic impurity.
No specific injuries or adverse events have been reported related to this recall. The FDA classified this recall as Class II, indicating a potential risk of serious health consequences.
Stop using the Entecavir Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc. or your healthcare provider for further instructions and guidance.
Consumers can reach Zydus Pharmaceuticals at 1-800-XYZ-XXXX. For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0002-2026.
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