Valsartan Recall

In July 2018, the U.S. Food and Drug Administration (FDA) announced the recall of several generic valsartan drugs. The valsartan recall was prompted by the discovery of a cancer-causing substance in the medications. More than 20 health agencies around the world issued similar valsartan recalls at the same time.

The FDA launched an investigation to determine the cause and impact of the valsartan contamination. The investigation led to many more recalls over the course of the following year. Additionally, the FDA found other blood pressure drugs affected by the impurities.

Why Was Valsartan Recalled?

Valsartan drugs were recalled because of contamination. During its investigation, the agency identified two possible carcinogens in valsartan medications.

The impurity that prompted the first recall was N-nitrosodimethylamine (NDMA). The FDA later discovered the second impurity, N-Nitrosodiethylamine (NDEA).

Both compounds have been shown to cause cancer in animal studies. Neither compound has been conclusively studied in humans. Because of this, these compounds are known as probable human carcinogens.

How Did the Contamination Happen?

The contamination was caused by a chemical reaction in the valsartan manufacturing process.

During the investigation, the FDA gained several major insights about the contamination:

• Valsartan suppliers in India and China sold contaminated valsartan to drug companies. These companies unknowingly used contaminated valsartan in their medications.
• A chemical reaction in the manufacturing process produced impurities such as NDMA and NDEA.
• The chemical reaction was the result of a new manufacturing process put in place years prior. Some valsartan products may have been contaminated for as long as four years.

How Do I Know if my Valsartan Has Been Recalled?

The FDA released a list of all the contaminated blood pressure medications. We've compiled the recalled valsartan medications in the expandable table below:

Is All Valsartan Affected by the Recall?

No. Only certain lots of valsartan made in India and China have been recalled. You can cross-check your valsartan drug label with our list of recalled valsartan medications above.

What to Do if You're Taking a Recalled Valsartan Medication

1. Do not stop taking your recalled valsartan prescription. High blood pressure can be a life-threatening condition. Discontinuing your medication without consulting a healthcare professional can lead to serious consequences.
2. Talk to your doctor. Your doctor can explain the cancer risks posed by contaminated valsartan. Your doctor can also prescribe an alternative medication to replace the contaminated one.
3. Consider legal action. Consumers have started filing lawsuits against valsartan manufacturers. To learn more about the lawsuits and eligibility requirements, visit our valsartan lawsuit page.

Additionally, contact your local pharmacist or the drug manufacturer for information about the proper disposal of recalled valsartan. You may also be eligible for a refund. Check your drug manufacturer's website or speak with your pharmacist for refund information.

Valsartan Recall FAQs

Is There a Diovan Recall?

Diovan -- the brand name version of valsartan -- has not been recalled.

To learn more about the drug valsartan and Diovan, visit our valsartan product page.

Is Losartan Recalled?

Manufacturers recalled numerous lots of losartan medications. For more information about the losartan recall and affected products, visit our losartan recall page.

What Blood Pressure Medicines Are Recalled?

During the investigation, the FDA identified three contaminated blood pressure medications:

• Valsartan
• Losartan
• Irbesartan

Is There a Valsartan Shortage?

Following countless recalls in 2018, safe valsartan medications were hard to find. Today, many valsartan medications remain on the FDA's list of drug shortages. Some of these medications have been indefinitely discontinued.

To combat shortages, the FDA approved a new generic valsartan medication in March 2019.