In July 2018 the FDA recalled several strains of the blood pressure medication valsartan and valsartan HCTZ. Both types of valsartan are hypertension prescriptions, originally sold under then brand name Diovan. Over the years prescription manufactures created generic equivalents to Diovan, the most notable generic valsartan manufacturer being Zhejiang Huahai Pharmaceuticals.
In the last few years, valsartan generic manufacturers, primarily China-based Zhejiang Huahai Pharmaceuticals, synthesized batches of valsartan using a different manufacturing process. Allegedly, the manufacturing process meant to increase product yield, therefore increasing the company's profit. However, the new process gave up the safeness of valsartan for the quantity of the drug manufacturers could produce.
Unsurprisingly, a deadly byproduct was the result of generic manufacturers' poor choices. FDA investigators uncovered dangerously high levels of known human carcinogens in specific strains of valsartan, These carcinogens, N-nitrodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), appear to be an impurity directly related to the manufacturing process.
NDMA and NDEA have been tied to an increased risk of serious health concerns. The FDA related that the levels of NDMA present in specific strains of valsartan exceed the maximum "safe" daily limit of NDMA as dictated by the EPA. Health concerns caused by these dangerous carcinogens include and are not limited to the below list of severe side effects.