Valsartan recall: what patients should know

Shelly Haberman

Nancy Hyland, Retail Pharmacy Director, Agnesian HealthCare

The US Food and Drug Administration (FDA) recently announced a voluntary recall of valsartan-containing products from three different generic manufacturers. These generic valsartan and valsartan/hydrochlorothiazide tablets may contain an impurity called N-nitrosodimethylamine (NDMA), which is considered a probable carcinogen based on testing done in labs.

  • Not all valsartan containing medicines are included in the recall. Valsartan containing medicines are being recalled from the following generic manufacturers only: 

–       Prinston Pharmaceutical (which distributes product as Solco Healthcare)

–       Actavis (owned by Teva Pharmaceutical)

–       Major Pharmaceuticals

  • Patients are urged to communicate with the pharmacy that dispensed their valsartan containing medicine to find out if their medicine is included in this recall.

–       The pharmacy can then work with the patient’s provider to prescribe an alternative treatment option.

  • Valsartan containing medicines are used to treat hypertension and heart failure, therefore patients should continue taking their medicine until they have a replacement product.  Discontinuing a valsartan product before receiving a replacement medication could cause serious health concerns.
  • It is expected that there will be a shortage on many valsartan products in the future. This could mean that if you are currently taking a valsartan product that is not part of the recall, your pharmacy may not be able to provide it for you until the shortage is over. If this happens, your pharmacy will need to work with you and your provider to identify an alternative therapy.


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