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In the first week of December 2018, two pharmaceutical companies recalled lots of Valsartan-containing products. Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure.

Mylan Pharmaceuticals (Mylan) and Teve Pharmaceuticals (Teve) both issued recalls at the end of November while Mylan issued another related recall on December 4^th of 2018. Both companies’ recalls are based on an impurity found in an active pharmaceutical ingredient (API) manufactured by Mylan known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. NDEA is typically found in minuscule amounts in certain foods, drinking water, air pollution, and certain industrial processes.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Mylan has directed customers to contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products. Mylan also directs that any adverse reactions be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Teve has directed its distributors and retailers to immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product. The company is notifying its distributors and customers by certified mail and is arranging for the return of returned recalled products. Adverse reactions or other problems experienced with the use of Teva’s products may also be reported to Teva directly at 888-838-2872 or to the FDA’s MedWatch Adverse Event Reporting program.

Patients should contact their pharmacist or physician who may advise them about alternative treatments. Patients who have been prescribed and are taking valsartan should continue doing so, since any risk of harm to the patient’s health may be increased if the treatment is stopped immediately with no alternative.