The FDA is alerting healthcare professionals and patients that several lots of a common high blood pressure and heart failure drug containing Valsartan have been recalled in the U.S. because they contain an impurity that poses a potential cancer risk.
Not all products manufactured by these foreign companies and distributed in the U.S. are being recalled.
Patients using high blood pressure medicines should look at the drug name and company on the label of their prescription and compare it to the FDA list or call their doctor/pharmacy to check whether their medicine has been recalled.
Here are the lists of Valsartan drugs that have been recalled, and Valsartan drugs that have not been recalled, by the FDA:
The Valsartan recall resulted because of the presence of the potentially cancer-causing impurity, N-nitrosodimethylamine (NDMA).
The FDA believes that the impurity may have been in the Valsartan-containing products for as long as four years.
NDMA is a known environmental contaminant that forms in both industrial and natural processes.
It has been used to make liquid rocket fuel, softeners, and lubricants and can be found naturally in meats, dairy products, and vegetables.
Exposure to high levels of NDMA may cause liver damage in humans, according to the U.S. Environmental Protection Agency.
Test results from the affected valsartan-containing medications found the amount of NDMA exceeds acceptable levels.
The FDA is working with drug manufacturers to determine the full impact of the unsafe impurities and to ensure future valsartan active pharmaceutical ingredients are not at risk of NDMA formation.
We will continue to update this page as we learn of changes due to the ongoing investigation.
