Valsartan is a drug used to treat high blood pressure and heart failure. In June 2018, the FDA announced a voluntary recall of Valsartan due to the discovery of carcinogenic chemicals in the drug. Anyone who has taken Valsartan must know what this recall entails and what to do if they take this medication.


FDA Guidance on Valsartan


The presence of N-nitrosodimethylamine (NDMA), a potential human carcinogen, has led to a voluntary recall of Valsartan. Valsartan, which is used to treat high blood pressure and heart failure, has been affected by changes in the manufacturing process that are believed to have caused this impurity. However, despite the recall, the FDA advises patients with serious health conditions to continue taking Valsartan until replacement doses are available. Moreover, the manufacturers affected are taking steps to remove the impurities from their products. Patients can check their prescription labels and manufacturer information to identify the recalled products. The recalled products include Valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, Ltd. Furthermore, it also includes Valsartan/Hydrochlorothiazide (HCTZ) from Solco Healthcare and Teva Pharmaceuticals, Ltd.


What to Do if You Currently Take or Have Taken Valsartan


Anyone who confirms their use of Valsartan medications affected by the recall should verify the medication’s manufacturer first. Then, check the company’s recall information regarding the recall. Most companies handle recalls differently. However, they typically encourage patients to continue taking the medication as prescribed until a safe replacement is available. If you have concerns about NDMA exposure, consult your primary care physician promptly. Your doctor may prescribe a replacement or substitute product to minimize disruptions in your medication schedule. The potential short-term cancer risk or long-term health implications after taking Valsartan remain unclear due to NDMA’s potential carcinogenic properties. Despite the potential carcinogenic exposure, Valsartan patients require consistent medication doses to manage serious medical conditions. Interruptions may lead to severe health problems. For now, patients taking recalled Valsartan medications should consult their physicians and refer to the manufacturers’ recall information.

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