Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Food & Drug Recalls

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan
due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a
substance that occurs naturally in certain foods, drinking water, air pollution, and industrial
processes, has been classified as a probable human carcinogen as per International Agency for
Research on Cancer (IARC).