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Valsartan® and Valsartan® / Hydrochlorothiazide Drug Recall


The drug manufacturers, Actavis/Teva, Prinston/Solco and Major Pharmaceuticals, issued a voluntary recall of the medication because of detection of trace amounts of N-nitrosodimethylamine (NDMA). NDMA has been classified as a likely cancer-causing agent by the International Research on Cancer. To date, there have been no confirmed reports of adverse events linked to this recall.

Valsartan is used for treatment of high blood pressure and heart failure. You should continue taking your medication, as the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment.

The US Food and Drug Administration (FDA) advises patients taking Valsartan should contact the doctor who prescribed the medication to discuss treatment, including alternative treatment options. You may find more information on these recalls by visiting the FDA’s website at: https://www.fda.gov/Safety/Recalls/default.htm.

Actavis/Teva Pharmaceuticals

https://www.fda.gov/Safety/Recalls/ucm613729.htm
  • Recall of 29 lots of Valsartan
  • Recall of 51 lots of combination Valsartan/HCTZ
  • Phone: 1-888-838-2872, option 3 or druginfo@tevapharm.com

Prinston/Solco Pharmaceuticals

https://www.fda.gov/Safety/Recalls/ucm613504.htm
  • Recall of all lots of Valsartan
  • Recall of all lots of Valsartan/HCTZ
  • Phone: 1-888-679-5120

Major Pharmaceuticals

https://www.fda.gov/Safety/Recalls/ucm613625.htm
  • Recall of all lots of Valsartan
  • Phone: 1-800-616-2471, option 1

MedImpact Direct is dedicated to maintaining patient safety. We appreciate your business and will continue to strive to provide you with the best possible service. On every MedImpact Direct prescription label, there is a description of the drug name with the manufacturer indicated.