Recall Active for Losartan Tablets

Legacy Pharmaceutical Packaging is recalling 179,544 bottles of losartan potassium tablets, 50 mg, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) in the drug, according to the April 10, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recalled tablets were manufactured for Torrent Pharma Inc., packaged by Legacy Pharmaceutical Packing, and were distributed in Arizona, Indiana, and Tennessee by The Kroger Co. The recall affects 30-count bottles (NDC 68645-494-54) from lots 180190 and 180191 (Exp. 10/20) and 181597 (Exp. 2/21).

Legacy Pharmaceutical Packaging voluntarily initiated the recall March 1, 2019. On April 1, 2019, the FDA designated it Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

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