December 6, 2018
Aurobindo Pharma Limited and Sciegen Pharmaceuticals, Inc. issued a voluntary recall for irbesartan on October 26 and October 30 respectively. The companies issued the voluntary recall due to trace amounts of NDEA (Nitrosodimethylamine) impurity found in the Active Pharmaceutical Ingredient (API). NDEA is classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).
Patients should take affected irbesartan medications back to their prescribing pharmacy. We’re encouraging our customers to continue taking their irbesartan medication as prescribed, as the health risks may be higher if the treatment is stopped immediately without an alternative treatment in place, and to contact their prescribing provider and/or pharmacy for next steps as soon as they can.
Find out about the recalled irbesartan products, including product name, catalog number, lot number, and expiration date: