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FDA recall update April 2019

Valsartan is used to treat high blood pressure and help prevent heart attacks and stroke. It is in the Angiotensin II receptor blocker (ARB) drug class.

The U.S. Food and Drug Administration (FDA), Health Canada, and the UK Medical Health Products Regulatory Administration have issued recalls and/or warnings on various versions of the drug valsartan, losartan, and Irbesartan. The problem originally relates to an impurity identified in the manufacturing process of the active pharmaceutical ingredient at one facility in China.

The U.S. FDA has announced they are assessing currently marketed ARB drugs for impurities. You can stay updated on the drugs the FDA has tested to be safe here: FDA Assessment for ARB Products

Mylan Pharmaceuticals has expanded its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by Mylan Laboratories Limited.

The European Medicines Agency has issued a ban in the EU on a version of valsartan manufactured by Mylan in India. The problem relates to an impurity identified in some batches of valsartan. The EMA has stated Companies that manufacture ARB drugs are being required to review their manufacturing processes so that they do not produce impurities. See updates here.

The Drugs Standard Control Organization (CDSCO) of India has not issued a safety warning on this product.

We advise patients to check with their providers and/or pharmacists to determine if their version of Valsartan was affected, and to discuss other treatment options, if necessary.

U.S. FDA Valsartan, Losartan, Irbesartan Recall
Mylan Valsartan Recall
Health Canada Valsartan Recall
UK MHRA Valsartan Recall
EMA Valsartan Press Release

UK MHRA Losartan Recall
Health Canada Losartan Recall