FDA WARNING_LETTER - Zydus Lifesciences Limited - June 01, 2026

On June 2, 2026, the FDA issued a Warning Letter to Zydus Lifesciences Limited following a records review initiated in November 2025 for its manufacturing facility in Himachal Pradesh, India. The document details significant failures to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering the firm"s drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

The primary violations involve inadequate testing of talc, a major component in the firm’s prescription drugs. The FDA found that Zydus failed to use appropriate laboratory methods to detect asbestos, a known carcinogen often found near talc deposits. Specifically, the company’s testing did not follow required standards to ensure the absence of contaminants. Furthermore, the agency identified serious data integrity issues, including the manipulation of laboratory reports to replace failing test results with passing ones. The facility"s Quality Unit was cited for failing to exercise proper oversight and for allowing statistically improbable identical results across multiple product lots.

Zydus Lifesciences is required to take several corrective actions, including hiring an independent laboratory to test all talc lots currently within their expiry period and conducting a comprehensive risk assessment for products already on the market, which may lead to recalls. The company must also submit a detailed remediation plan to address laboratory deficiencies and strengthen the authority of its Quality Unit. A formal response outlining these improvements is required within 15 working days.