Lupin Pharmaceuticals Recalls All Irbesartan Tablets Over Potential Impurity

Lupin Pharmaceuticals is recalling all batches of its irbesartan and irbesartan/hydrochlorothiazide tablets in the U.S. over concerns the blood pressure drugs may contain N-nitrosoirbesartan, a likely carcinogen.

Irbesartan is an angiotensin II receptor blocker prescribed to treat hypertension and protect kidneys from diabetes-related harm. Hydrochlorothiazide is a diuretic also used to treat high blood pressure.  

The Indian drugmaker, which stopped selling the tablets in January, said it had received four adverse event reports from October 2018 through September 2021 about irbesartan use but none about the combination product.