FDA Recalls Valsartan Updated

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, Aurobindo Pharma USA (updated)
  • valsartan/hydrochlorothiazide (HCTZ), Aurobindo Pharma USA (updated)
  • valsartan, A-S Medication Solutions LLC
  • valsartan, Bryant Ranch Prepack Inc.
  • valsartan, H J Harkins Company
  • valsartan, Major Pharmaceuticals
  • valsartan, Northwind Pharmaceuticals
  • valsartan, Solco Healthcare
  • valsartan, Teva Pharmaceuticals Industries Ltd or Actavis
  • valsartan/hydrochlorothiazide (HCTZ), A-S Medication Solutions LLC
  • valsartan/hydrochlorothiazide (HCTZ), AvKARE
  • valsartan/hydrochlorothiazide (HCTZ), Proficient Rx LP
  • valsartan/hydrochlorothiazide (HCTZ), Remedy Repack
  • valsartan/hydrochlorothiazide (HCTZ), Solco Healthcare
  • valsartan/hydrochlorothiazide (HCTZ), Teva Pharmaceuticals Industries Ltd
  • valsartan, Mylan
  • valsartan/amlodipine besylate, Mylan
  • valsartan/amlodipine besylate, Teva Pharmaceuticals Industries Ltd
  • valsartan/amlodipine besylate/hydrochlorothiazide (HCTZ), Teva Pharmaceuticals Industries Ltd
Published on: December 3, 2018, 00:01 a.m. ET
Last updated on: July 1, 2019, 06:27 a.m. ET