UPDATE on angiotensin II receptor blocker (ARB) recalls - FDA alerts patients and health care professionals to Teva’s recall and Legacy’s expanded recall of losartan medication due to NMBA - Drug Information Update

FDA is alerting patients and health care professionals to a voluntary recall of 44 lots of losartan potassium tablets manufactured by Teva Pharmaceuticals and labeled as Golden State Medical Supply due to the detection of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The recalled products were made with active pharmaceutical ingredient (API) manufactured by Hetero Labs. Teva is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million.

Additionally, Legacy expanded its recall to include one additional lot of losartan tablets made with API manufactured by Hetero Labs.

Manufacturers should contact FDA’s Drug Shortages Staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. FDA will determine, on a case-by-case basis, whether lots containing NMBA greater than 0.96 ppm should be released for distribution.

The agency also updated the list of recalled losartan medicines.