Drug Safety Alerts

Losartan Potassium and Hydrochlorothiazide Tablets Consumer-Level Recall

1/22/2019

On January 22, 2019, Torrent Pharmaceuticals issued a consumer-level recall of losartan potassium and hydrochlorothiazide tablets. This recall was issued due to the detection of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

A complete list of the affected products and lot numbers is provided here:

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on losartan potassium and hydrochlorothiazide tablets 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. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking losartan potassium and hydrochlorothiazide tablets to contact their prescriber.

For more information, health care providers may contact Torrent Pharma Inc. at 1-800-912-9561, 8:00 am to 5:00 pm (ET). You may also contact the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.