According to Zydus, the communication refers to technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements.
The company said it does not expect the warning letter to have any impact on current operations or supplies from the Baddi facility.
Zydus noted that the USFDA last inspected the Baddi plant in August 2025. Following the inspection, the company received an Establishment Inspection Report (EIR) in October 2025, with the facility classified under the Voluntary Action Indicated (VAI) category.The company said it is working with the USFDA to complete the required remediation measures and will respond to the regulator within the stipulated timelines.
A warning letter is issued by the USFDA when it identifies significant regulatory concerns and typically requires companies to undertake corrective actions. Failure to adequately address the observations can lead to further regulatory action.
Following the announcement, shares of Zydus Life fell as much as 3%, but have since rebounded and are currently trading abut 1% up at ₹1,068.20. The stock has gained 17% this year, so far .
Also read: Zydus Lifesciences share buyback opens June 4; Check entitlement ratio and details here
