FDA updates health care professionals and patients on recent valsartan recalls - Drug Information Update

Press Announcements > FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

The U.S. Food and Drug Administration is updating health care professionals and consumers following a recent FDA press release about voluntary recalls of several drug products containing the active pharmaceutical ingredient (API) valsartan. Valsartan is used to treat high blood pressure and heart failure. Not all products containing valsartan are being recalled, and this update will clarify which valsartan-containing products are being recalled.

The recalled products contain an impurity, N-nitrosodimethylamine (NDMA), in the API manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China. The presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured. Some levels of the impurity may have been in the valsartan-containing products for as long as four years.

What should patients know:

• Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.
• Not all valsartan-containing medications are affected and being recalled.
• If you are taking any medication containing valsartan, compare the information on your prescription bottle with the information in this list (company, National Drug Code, lot number) to determine if your current medicine has been recalled. If you are not certain, contact your pharmacist.
• If you have medicine included in the recall, contact your pharmacist. The pharmacist may be able to provide you with valsartan made by another company. If not, contact your doctor immediately to discuss other treatment options.

What health care professionals should know: 

• FDA has determined the recalled valsartan products pose an unnecessary risk to patients. Therefore, FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient’s medical condition.
• If you have medication samples from these companies, quarantine the products and do not provide them to patients.

For more information, please visit: Valsartan Recalls Update.