Three companies recall blood pressure medications due to possible contamination with a carcinogen

Several prescription drugs containing the active ingredient valsartan, used to treat high blood pressure and heart failure, are being recalled because they may contain an impurity, N-nitrosodimethylamine or NDMA, a probable human carcinogen.

The U.S. Food and Drug Administration said the presence of NDMA could be related to changes in the way the active substance was manufactured.

The FDA’s review includes 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 to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product, the FDA said.

To find out if 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 isn’t 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 is posted to the FDA’s website.

Patients should also contact their health care professional – 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 or an alternative treatment option.

The companies listed below are recalling all lots of non-expired products that contain valsartan supplied by a third party. Not all valsartan-containing medicines distributed in the United States have the valsartan active pharmaceutical ingredient or 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

“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is why we’ve asked these companies to take immediate action to protect patients.”

The FDA’s investigation will continue, and the agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.