Strides' Italian unit Beltapharm SPA received an import alert on Monday, according to the US FDA website.
The alert applies to skin care products including Beneks Cleartone Fast Action Cream, Beneks Cleartone Fast Action Gel and Beneks Fashion Fair Cream.
The company, however, said that its Italian unit has only one drug application - Imiquimod cream - approved for the US market, used to treat some skin diseases.
It further said that the products mentioned by the US drug regulator in its import alert are for an African customer., adding that it has no role in the distribution of those products in the United States.
"The Company is working with the US FDA and the African customer on the circumstances of how these products reached the US markets," Strides said in a filing to bourses.
As of 3:22 p.m., shares in Strides were trading at Rs 712.00 apiece on the BSE, down 0.52 per cent from the previous close.
Copyright @ Thomson Reuters 2014