Only certain manufacturers have had their valsartan recalled, with specified batch codes included in the recall.

What is Valsartan?

Valsartan is a medication used to treat high blood pressure and heart failure. The drug may also be prescribed after heart attacks to increase life expectancy, according to WebMD. The drug is an angiotensin receptor blocker (ARB), meaning that it relaxes blood vessels in the body to improve blood flow. Other ARBs include losartan and irbesartan.

Why is Valsartan Recalled?

The trouble started in May 2018. At this time, the European Medicines Agency announced that they had found valsartan medication was contaminated with N-nitrosodimethylamine (NDMA). This chemical is naturally found in low levels in certain food products but can also be a byproduct of several industrial processes. Evidence has resulted in NDMA being classified as a “probable human carcinogen.”

Because NDMA was found in certain valsartan medications produced by Chinese pharmaceutical company Zhejiang Huahai Pharmaceuticals, European regulators started to recall valsartan medications that could potentially be contaminated. The FDA followed suit in July 2018 when they announced that several manufacturers would be recalling their valsartan.

Since then, the recall has been expanded to numerous manufacturers and countless batch lots. The reason so many different manufacturers are affected by the recall comes down to their suppliers. All of the affected manufacturers purchased active pharmaceutical ingredients from the labs where the contamination started.

After manufacturers made their final product, it could be distributed or sold to repackaging companies, thereby involving yet another company.

This means that the Valsartan problem snowballed to affect a wide number of finished products.

“Multiple generic pharmaceutical companies will buy all of their API supply for each drug from the same manufacturer, usually in batches meant to produce several weeks of supply for each medication,” internal medicine specialist and consumer advocate Dr. David Belk told Healthline. “That means that, if there’s a problem with the production of a single batch of an API, it can ruin the whole U.S. supply of that drug for several weeks.”

After impurities were found in valsartan medications, regulators started to check other ARB medications for similar contamination. As a result, batches of losartan and irbesartan have also been recalled.

It is unclear what the long term health effects of the contamination will be. The FDA is reportedly researching the long term effects of NDMA exposure and trying to figure out how patients will be affected based on their dosage and how long they took the contaminated medication.

Is All Valsartan Recalled?

Although the valsartan contamination has had widespread effects, not all valsartan is recalled. Only certain manufacturers are included in the recall. Even within those manufacturers’ batches, only a select number of lots are affected. A full list of affected manufacturers and lot numbers is available on the FDA’s website.

As soon as the recalls began, pharmacies were instructed to return the recalled medications to the manufacturers. This means it is unlikely that consumers are still taking contaminated blood pressure medication, but patients can always speak to their pharmacist to double check.