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Dabur India says US FDA issues import alert for Silvassa plant drugs

12-Jun-2026 | 10:41
Dabur India said the United States Food and Drug Administration (USFDA) issued Import Alert 66-40 for drugs made at part of its Silvassa facility after an inspection flagged data integrity and maintenance deficiencies.

The company said the US FDA had conducted an inspection at the plant and issued inspectional observations, to which it had submitted responses. Following a review of the company's responses and the Establishment Inspection Report (EIR), the regulator issued the import alert on June 10, 2026.

Dabur clarified that the order pertains only to a small section of the Silvassa manufacturing facility involved in private-label products and has no material impact on the company's financials, operations or other business activities. The affected products generate insignificant revenue for the company, it added.

The company said its domestic products are not covered by the import alert and the Silvassa plant continues to operate normally.

Dabur added that it is engaging with the US FDA through corrective and preventive action plans to address the identified gaps. The company also said multiple internal and independent third-party tests have not identified any out-of-specification issues or other concerns with its products.

The FMCG major said it is implementing alternate sourcing strategies for its US customers while continuing to focus on product quality and consumer safety.

Dabur India is one of India's leading FMCG companies. The company manufactures personal care, healthcare and food products. Its portfolio includes eight major power brands- Dabur Chyawanprash, Dabur Honey, Honitus, PudinHara and Dabur Lal Tail in the healthcare catrogory, Dabur Amla and Dabur Red Paste in the personal care and Real in the food & beverages space.

The company reported 15.14% jump in consolidated net profit to Rs 368.60 crore on 7.35% increase in revenue from operations to Rs 3038.02 crore in Q4 FY26 over Q4 FY25.

Shares of Dabur India rose 0.44% to Rs 424.05 on the BSE.

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