Several medications containing the active ingredient Valsartan have been recalled by the United States Food and Drug Administration over contamination issues. The impurity, known as N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen.
The Recalls
The initial round of recalls addressed Valsartan produced by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals. It also extended to Valsartan/Hydrochlorothiazide (HCTZ) produced by both Solco and Teva.
In addition, Teva Pharmaceuticals and generic manufacturer Mylan Pharmaceuticals have voluntarily recalled various strengths of Valsartan tablets—as well as Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) tablets distributed in the United States between March 2017 and November 2018. These products have been found to contain N-nitroso-diethylamine (NDEA), another probable human carcinogen. A list of Mylan’s recalled drugs is available here.
According to the United States Department of Health and Human Services, exposure to NDMA has been known to cause tumors in the respiratory tract, liver, kidneys, and blood vessels of animals. In humans, exposure to NDMA can reduce the function of the liver, kidneys, and lungs. Symptoms of overexposure can include:
