FDA announces voluntary recall of several medicines containing valsartan

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine, which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Recalled Products

MEDICINE	COMPANY
Valsartan	Major Pharmaceuticals
Valsartan	Solco Healthcare
Valsartan	Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)	Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)	Teva Pharmaceuticals Industries Ltd.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

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