FDA Announces Voluntary Recall

July 18th, 2018

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(NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) 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.

It is important that you:

1. Check the list and call your pharmacy, not all varsartan is being recalled

2. Do not abruptly stop the medication without talking to your provider and starting a replacement drug. If the pharmacy confirms your valsartan has been recalled, call your provider.

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 and Company
Valsartan – Major Pharmaceuticals
Valsartan – Solco Healthcare
Valsartan – Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Industries Ltd.