Dabur India Ltd. announced that the US FDA has issued an Import Alert (IA) 66-40, effective June 10, 2026, concerning drugs manufactured at its Silvassa plant. The alert follows an inspection that identified deficiencies in data integrity and maintenance. Dabur states that this impacts only a small portion of private label products with insignificant revenue and that domestic products remain unaffected. The company is actively implementing corrective actions and engaging with the US FDA.
US FDA Import Alert Issued for Silvassa Plant
Dabur India Ltd. has been notified by the United States Food & Drug Administration (US FDA) regarding an Import Alert, IA 66-40, effective from June 10, 2026. This alert pertains to drugs manufactured at the company’s plant located in Silvassa, Dadra and Nagar Haveli. The action by the US FDA stems from an inspection that identified certain deficiencies related to data integrity and maintenance lapses at the facility.
Company Response and Impact Assessment
Following the inspectional observations, Dabur India Ltd. stated that it has submitted suitable responses to the US FDA. Upon review of these responses and the Establishment Inspection Report (EIR), the Import Alert was issued. The company has clarified that the alert concerns only a small part of its manufacturing operations related to private label products, which contribute insignificantly to its overall revenue. Crucially, domestic products manufactured at the Silvassa plant are not covered by this alert and remain unaffected. The Silvassa plant continues to be operational.
Corrective Actions and Commitment to Quality
Dabur India Ltd. is actively engaging with the US FDA by providing detailed corrective and preventive action plans. The company is implementing robust measures to address the identified gaps. Furthermore, multiple internal and external third-party testing initiatives have shown no out-of-specification results or any other concerns with any of the company’s products. Dabur reiterated its strong commitment to maintaining product quality and ensuring consumer safety, emphasizing that this is a one-off incident. The company is also exploring alternate sourcing strategies for its US customers.
Disclosure Timeline
The information regarding the Import Alert was received by the Company on June 10, 2026, at 3:29 a.m. The company assures that there has been no material delay in disclosure, as it was in the process of reviewing the order and evaluating its next steps. The comprehensive information regarding this matter will also be made available on Dabur India Ltd.’s official website.
Source: BSE
