Zydus Pharmaceuticals (USA) Inc., a subsidiary of Ahmedabad-based Zydus Lifesciences, has initiated a voluntary recall of 8,784 bottles of its liver infection treatment, Entecavir, from the U.S. market. The recall was announced after the drug failed to meet impurity and degradation specifications during stability testing. Classified as a Class II recall by the U.S. Food and Drug Administration (FDA), the action indicates that while use of the affected product may cause temporary or medically reversible adverse health effects, the probability of serious health consequences is low.

The recalled product, Entecavir tablets USP 0.5 mg, is used primarily in the treatment of chronic hepatitis B virus infection. According to reports, the affected batches were manufactured at Zydus’s Moraiya facility in India and distributed across the U.S.

Zydus has stated that the recall is being undertaken proactively and in coordination with the FDA to ensure patient safety. The company continues to strengthen its quality systems and manufacturing controls to prevent future deviations.

This recall comes as the Indian pharmaceutical industry faces increasing global scrutiny over manufacturing and quality compliance, particularly in the U.S. market, where Indian drugmakers maintain a dominant presence as key generic medicine suppliers.