Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ wholly-owned subsidiary--- Sun Pharmaceutical Industries Inc is voluntarily recalling one lot of Riomet ER oral suspension in the US market, due to the presence of a probable human carcinogen above the acceptable daily intake limit.

The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable acceptable daily intake (ADI) limit established by the United States Food and Drug Administration (USFDA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. This recall is being conducted with the knowledge of the USFDA.

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.