The U.S. Food and Drug Administration has announced the recall of several drug products used to treat high blood pressure and heart failure that contains an impurity that may cause cancer.

Some drugs containing the active ingredient valsartan may contain N-nitrosodimethylamine, which is classified as a probable human carcinogen based on results from laboratory tests.

However, not all products containing valsartan are being recalled.

The presence of N-nitrosodimethylamine is thought to be related to changes in the way the active substance was manufactured, according to the USDA.

The FDA is 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.

Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines are being advised to continue taking their medicine until they have a replacement product, according to the FDA.

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company.

This information will be posted on the FDA’s website.

Patients should also contact their healthcare professional such as the pharmacist who dispensed the medication or doctor who prescribed the medication if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

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 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 agency encourages patients and healthcare professionals to report any adverse reaction to the FDA’s MedWatch program.

Included in the announcement is Solco Healthcare LLC., which is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.

The company says it has not received any reports of adverse events related to the recall.

Anyone having questions regarding this recall may call 1-866-931-9829, Option 5, between the hours of 9:00 a.m. to 5:00 p.m. EST Monday through Friday.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Additional information regarding this recall affected products’ lots and expiry dates can be found at

or to download at

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.