Millions of Americans rely on valsartan-based medications to manage high blood pressure and heart conditions. They take these pills daily, trusting that the medication that is supposed to protect their heart is safe. But testing revealed that batches of valsartan were contaminated with NDMA—N-nitrosodimethylamine—a chemical classified as a probable human carcinogen. Some batches contained NDMA at levels more than 200 times the acceptable safe limit. Patients who took these contaminated pills were unknowingly ingesting a cancer-causing substance with every dose.

What Happened

The contamination was traced to manufacturing defects at overseas pharmaceutical facilities, particularly Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India. Changes in manufacturing processes created conditions that generated NDMA as a byproduct—a fact that went undetected for years. Testing eventually revealed contamination levels ranging from 3 to 177 times the safe limit, with some batches showing NDMA concentrations more than 200 times what is considered acceptable.

The FDA issued recalls covering numerous lots of valsartan, as well as related medications losartan and irbesartan. But by the time the recalls were announced, many patients had already been taking contaminated medication for months or even years.

Health Risks

NDMA is classified as a probable human carcinogen. Long-term exposure—even at levels below what was found in contaminated valsartan—has been associated with increased risks of various cancers. Patients who unknowingly consumed this chemical with their daily blood pressure medication were exposed to a cancer risk they never agreed to and never knew about.

The cruelest irony is that these were patients who were already managing a serious health condition. They were doing exactly what their doctors advised—taking their medication every day. And the medication itself was putting them at risk.

Who May Be Eligible

Patients who took valsartan, losartan, or irbesartan during the period covered by the FDA recall and were subsequently diagnosed with cancer may be eligible to file a claim. Eligibility is based on the specific manufacturer of the medication taken, the duration of use, and the cancer diagnosis received. Patients who were not informed about the recall by their healthcare providers may have additional grounds for claims.

Current Litigation Status

More than 1,300 cases are pending in a federal multidistrict litigation before a judge in New Jersey. Bellwether trials—the first cases to go before a jury—are underway, with expert testimony and trial preparations continuing into 2026. The litigation targets both the overseas manufacturers responsible for the contamination and the domestic pharmaceutical companies that distributed the products.

If you took valsartan and were subsequently diagnosed with cancer, you may have the right to pursue compensation from the companies responsible for the contamination. Beverly Wilshire Law APC can review your case at no cost. Call (310) 424-5566 or visit bevwilshire.com—we’re here to guide you in the right direction.