Additional Bottles of Losartan Potassium Tablets Recalled

Preferred Pharmaceuticals Inc. is recalling 30- and 90-count bottles of losartan potassium tablets after the US Food and Drug Administration (FDA) confirmed the presence of N-Methylnitrosobutyric acid (NMBA) in the finished product, according to the May 22, 2019, FDA Enforcement Report. 

The recalled losartan was manufactured by Torrent Pharma Inc. and distributed in California, Georgia, and Indiana. Included in the recall are 30-count bottles (NDC 68788-0048-03) from lot A1818G, batch 01181807 (Exp. 3/20). Also recalled are 90-count bottles (NDC 68788-0048-09) from lot L0517L, batch 12051712 (Exp. 3/20). 

Preferred Pharmaceuticals voluntarily initiated the recall April 30, 2019. On May 16, 2019, the FDA designated the recall Class II. The designation communicates use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Losartan is a prescription drug used to treat patients with high blood pressure, reduce stroke risk in patients with high blood pressure and an enlarged heart, and treat kidney disease in patients with diabetes.  

—Jolynn Tumolo