The Food and Drug Administration (FDA) has announced that Torrent Pharmaceuticals Limited is voluntarily expanding the recall of its blood pressure medication over concerns the tablets contain small amounts of a cancer-causing ingredient. According to the statement from the FDA, the expanded recall includes “an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP. The company will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled.
Losartan is a generic angiotensin II receptor blocker, or ARB. It is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy, and nephropathy in Type 2 diabetic patients. Over the last year, numerous batches of generic ARBs have been withdrawn from the market due to similar issues.
The FDA reported that traces of unexpected impurities, N-Methylnitrosobutyric acid (NMBA), were found in batches of Losartan manufactured with active pharmaceutical ingredients. NMBA is a known animal and potential human carcinogen. Torrent said the recall only affects products found to have more than the FDA-allowable amount of NMBA.
Health officials are urging patients to contact their health physician or pharmacist to receive alternative treatment before returning their medication. The FDA statement says, “Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”
This will be the fifth time the company has expanded the recall. The fourth was announced in April. The recall was first announced in January. Consumers should contact a doctor if they have experienced any health issues that may be related to these drugs.