FDA Announces Recall for Several Heart Medications Containing Valsartan

FDA Announces Recall for Several Heart Medications Containing Valsartan

The FDA has announced a voluntary recall of several drug products containing the active ingredient valsartan, which used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer), which was found in the recalled products. 

The presence of NDMA is thought to be related to changes in manufacturing, and the FDA recommends that because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party.

  • Valsartan – Major Pharmaceuticals
  • Valsartan – Solco Healthcare
  • Valsartan – Teva Pharmaceuticals Industries Ltd.
  • Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
  • Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Industries Ltd.

For more information, read the FDA Press Announcement.