Losartan was recalled because of a carcinogenic chemical impurity known as N-nitrosodiethylamine (NDEA), which is a byproduct of the drug manufacturing process.
Torrent Pharmaceuticals announced an initial recall on December 20 after finding NDEA in 2 lots of the active ingredient manufactured by Hetero Labs Limited.
On January 3, Torrent announced an expanded recall covering 12 lots of the dug.
The recall involves Lorsartan Potassium Tablets, USP, in 100-mg, 50-mg and 25-mg strengths. They were sold and in bottles of 30, 90, and 1,000 count, with expiration dates ranging from 04/2019 through 05/2021.
Losartan is a generic version of the blood pressure medication Cozaar®, and because it is meant to be taken every day, a carcinogenic impurity could potentially raise a user’s risk of cancer.
NDEA is a byproduct of industrial processes that is listed as a probable human carcinogen by the International Agency for Research on Cancer (IARC). Problems with NDEA impurities have also been linked to the blood pressure drugs irbesartan and valsartan.