Dabur India Faces US FDA Import Alert Over Silvassa Manufacturing Unit

Dabur India Limited has informed the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE) regarding regulatory action taken by the United States Food & Drug Administration (US FDA) against a part of its manufacturing operations. The disclosure was made on June 11, 2026 under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

According to the company, the US FDA had conducted an inspection of its manufacturing facility located in Silvassa, Dadra and Nagar Haveli. During the inspection, the regulator has come across certain deficiencies concerning data integrity and maintenance practices. Following the inspection, the company submitted responses to the objections raised by the authority. After examining the response by the company and the Establishment Inspection Report (EIR), the US FDA issued Import Alert 66-40 on June 10, 2026 covering drugs manufactured at the concerned facility. Dabur stated that the Import Alert was issued on the basis of the observations recorded during the inspection and the corrective measures proposed by the company.

The company clarified that no violation or contravention has been alleged against it. It further stated that this regulatory action pertains only to a limited portion of the Silvassa manufacturing plant that produces private-label products.

Dabur also emphasized that the Import Alert is not expected to have any material impact on the company’s financial position, operations, or business activities and its domestic products are not covered by the Import Alert and remain unaffected. The Silvassa facility continues to operate normally despite the regulatory action.

In its disclosure, the company stated that it is actively engaging with the US FDA and has been providing corrective and preventive action plans to address the concerns raised during the inspection. The company will continue to cooperate with the regulator and take all necessary measures to resolve the matter at the earliest and ensure alternate sourcing strategies are being implemented to ensure uninterrupted supplies to customers in the United States while regulatory issues are being addressed.