Valsartan Recall

A valsartan recall has been issued for certain blood pressure and heart failure medications, after it was determined that the drugs could be tainted with a potentially cancer-causing chemical.

Contact a Valsartan Recall Lawyer Today

The nationwide law firm of Bernstein Liebhard LLP is investigating the valsartan recall. If you or someone you love were treated with a valsartan-containing drug and were later diagnosed with cancer, please contact our office at (888) 994-5118 to arrange for your free, no-obligation valsartan lawsuit review.

Why Was a Valsartan Recall Necessary?

Valsartan was first approved by the U.S. Food & Drug Administration (FDA) in 1996 and was sold under the brand name Diovan. Dozens of generic versions have been launched since valsartan lost patent protection in 2012.

Valsartan is indicated for the treatment of high blood pressure and heart failure. It is also used to reduce the risk of cardiovascular mortality in patients who have suffered a heart attack.

In July 2018, the FDA announced a valsartan recall after tests indicated that certain medications made with an Active Pharmaceutical Ingredient (API) supplied by the Chinese company Zhejiang Huahai Pharmaceuticals were tainted with N-nitrosodimethylamine (NDMA).

NDMA can cause liver damage and has been designated a probable human carcinogen by the U.S. Environmental Protection Agency.

What Medications are Included in the Valsartan Recall?

The valsartan recall does not include all products on the market, as not all contain API from Zhejiang Huahai Pharmaceuticals. To view a list of valsartan medications not affected by this recall, click here.

The initial recall was announced on July 13, 2018. However, more valsartan-containing drugs were added to the recall list in the ensuing weeks. As of August 9th, products distributed by the following companies were affected:

  • A-S Medication Solutions LLC
  • AvKare
  • Bryant Ranch Prepack Inc.
  • Cambler Pharmaceuticals
  • J. Harkins Company Inc.
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • Northwind Pharmaceuticals
  • NuCare Pharmaceuticals Inc.
  • Princton Pharmaceuticals labeled as Solco Healthcare
  • Proficient Rx
  • Remedy Repak
  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Teva Pharmaceuticals USA labeled as Actavis

To view a complete list of products included in the valsartan recall, click here.

What is the Risk from Recalled Valsartan?

The valsartan medications included in this recall contain NDMA beyond levels considered acceptable. NDMA has been found to increase the occurrence of cancer in animal studies, which prompted the EPA to designate the chemical a probable human carcinogen.

The presence of NDMA in recalled valsartan appears to be associated with a change in manufacturing processes by Zhejiang Huahai Pharmaceuticals, which occurred in 2012. Thus, tainted valsartan products may have been in circulation for the past 4 years.

FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people.

What Should Patients Do?

Patients taking valsartan medications should check the product label to determine if the drug was distributed by any of the companies involved in the recall. Contact the pharmacy where the prescription was filled if the label does not list a manufacturer.

Individuals who have been using a medication subject to the valsartan recall should not stop taking the drug, as the conditions being treated are serious. Contact a doctor as soon as possible to arrange for an alternative treatment.

Learn if You are Eligible to File a Valsartan Lawsuit

Individuals who were diagnosed with cancer possibly related to the valsartan recall could be eligible for compensation for all of their injury-related damages. To learn if you are eligible to file a lawsuit for contaminated valsartan, please call (888) 994-5118 for your free, no-obligation legal consultation.

  1. FDA (2018) “FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity”
  2. FDA (2018) “FDA updates on valsartan recalls”
  3. EPA (2014) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)”
Last Modified: November 21, 2018

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