FDA Recalls Valsartan

The U.S. Food and Drug Administration (FDA) is alerting health care professionals and their patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled.

Only those valsartan-containing medicines which have the valsartan active pharmaceutical ingredient (API) supplied by a specific third-party company are affected. The supplier has stopped distributing its valsartan API and the FDA is working with the affected manufacturers to reduce or eliminate the valsartan API impurity from future products.

The manufacturers listed below are recalling all non-expired products that contain valsartan:

  • valsartan, Major Pharmaceuticals
  • valsartan, Solco Healthcare
  • valsartan, Teva Pharmaceuticals Industries Ltd or Actavis
  • valsartan/Hydrochlorothiazide (HCTZ), Solco Healthcare
  • valsartan/Hydrochlorothiazide (HCTZ), Teva Pharmaceuticals Industries Ltd

For more information, please visit the FDA website.

Published on: July 20, 2018, 14:07 PM ET
Last updated on: July 20, 2018, 14:39 PM ET