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Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall to 10 Lots of Losartan potassium tablets USP


The drug manufacturer, Torrent Pharmaceuticals Limited, issued a voluntary recall of the medication due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA). NDEA 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 according to the International Agency for Research on Cancer (IARC). To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. You should continue taking your medication, as the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment.

The US Food and Drug Administration (FDA) advises patients taking Losartan should contact the doctor or healthcare provider who prescribed the medication to discuss treatment, including alternative treatment options. You may find more information on these recalls by visiting the FDA’s website at: https://www.fda.gov/Safety/Recalls/default.htm.

Torrent Pharmaceuticals Limited: https://www.fda.gov/Safety/Recalls/ucm629213.htm Recall of 10 lots of losartan. Phone: 1-800-912-9561

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
  • Medinfo.Torrent@apcerls.com

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

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