The warning letter was issued in response to a request for records pursuant to a section of the Federal Food, Drug, and Cosmetic Act, and does not pertain to any on-site inspection of the facility by the US FDA.

The communication references technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements.

'We believe that the said warning letter will not impact current operations and supplies from the Baddi site,” Zydus Lifesciences said in a statement.

The Baddi manufacturing facility was last subjected to an on-site inspection by the USFDA in August 2025.

Subsequent to the conclusion of the inspection, the company received the establishment inspection report (EIR) in October 2025, with the final compliance status classified as voluntary action indicated (VAI).

Zydus Lifesciences is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company’s consolidated net profit jumped 8.68% to Rs 1,272.5 crore on 16.22% increase in revenue from operations to Rs 7,587 crore in Q4 FY26 over Q4 FY25.