Voluntary recall issued for blood-pressure drugs over substance linked to cancer

Leslie Hanson
January 5, 2019

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.

The new recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets, according to the FDA.

The impurity in the product is N-nitrosodiethylamine (NDEA), a substance that naturally occurs in some food, drinking water, air pollution and industrial processes.

Torrent and Hetero Labs are both based in India.

He added not every Accord and Dexcel product had been affected and patients should seek the advice of their doctor before they stop taking their medication.


The recall comes about two months after Teva Pharmaceuticals recalled two of its blood pressure drugs for the same concerns.

The products subject to recall are listed on the FDA's website and packaged in bottles.

While the drug impurities are serious enough to warrant these callbacks, halting the use of a blood pressure medication can cause other serious medical issues. Those who take the recalled drug need to contact their pharmacist or doctor before deciding to stop taking the medication. And in November, Mylan Pharmaceuticals also issued a voluntary recall of some of its Amlodipine and Valsartan products for the same reason.

"At present, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients". The U.S. Food and Drug Administration announced on July 13, 2018 the recall of the heart medicine valsartan, made by Chinese firm Zhejiang Huahai, which was found to be contaminated by a carcinogen.

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