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Aurobindo Initiates Voluntary Nationwide Recall of 80 Lots of Valsartan Tablets, Amlodipine and Valsartan Tablets, and Valsartan and Hydrochlorothiazide Tablets

The drug manufacturer, Aurobindo Pharma USA, issued a voluntary recall of the medication due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA). NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

Valsartan is used for treatment of high blood pressure and heart failure. You should continue taking your medication, as the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment.

The US Food and Drug Administration (FDA) advises patients taking Valsartan should contact the doctor who prescribed the medication to discuss treatment, including alternative treatment options. You may find more information on these recalls by visiting the FDA’s website at:

Aurobindo Pharma USA, Inc : Recall of 80 lots of valsartan containing products Phone: 1-866-850-2876 Option 2

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email (live calls received 9 am -5:00 pm Eastern Time).

MedImpact Direct Mail® is dedicated to maintaining patient safety. We appreciate your business and will continue to strive to provide you with the best possible service. On every MedImpact Direct Mail® prescription label, there is a description of the drug name with the manufacturer indicated.