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Valsartan Recall Due To Cancer Risk

The FDA has issued a recall for Diovan, Diovan HCT, Exforge, Exforge HCT and Entresto from multiple manufacturers. Researchers discovered that these drugs could be contaminated with N-nitrosodimethylamine or NDMA. NDMA can cause liver cancer.


About Valsartan

ValsartanManufactured by Major Pharamascetucials, Teva Pharmaceuticals, and other companies, valsartan is a cardiovascular drug to treat high blood pressure or hypertension. The FDA approved the medication in adults and children aged 6 and up. The drug can also treat adults for heart failure along with reducing the risk of death in those who recently had a heart attack. It is available as a stand-alone medication or as valsartan HCTZ, which combines valsartan with the diuretic hydrochlorothiazide. Common medications containing the valsartan are Diovan, Diovan HCT, Exforge, Exforge HCT or Entresto.


Valsartan Recall

In May 2018, the European Medicines Agency announced that investigators found a potentially dangerous impurity in valsartan medications sourced from Zhejiang Huahai Pharmaceuticals, a Chinese pharmaceutical manufacturer. They identified the substance as N-nitrosodimethylamine or NDMA. Healthcare authorities have classified NDMA as a possible human carcinogen. Then, Europe began recalling medications potentially tainted with valsartan along with urging pharmacies to pull the medication from the shelves.
The announcement also suggests that changes in production at the Chinese manufacturing facility caused the NDMA presence. Also, the facility made the changes in 2012. Therefore, the tainted valsartan could have been on the marketing for several years before the recent discovery.


The U.S. Valsartan Recall

In July 2018, the FDA has asked three manufacturers of generic valsartan medication to voluntarily recall it from the U.S. market. Also, the agency asked pharmacists to return contaminated medications to the manufacturers. Furthermore, the agency is continuing to investigate the NDMA levels to asses cancer risks in those who already ingested the medication.

The FDA named the following manufacturers in the recallMedication


  • Major Pharmaceuticals valsartan products
  • Solco Healthcare valsartan products
  • Teva Pharmaceuticals Industries Ltd. valsartan products
  • Solco Healthcare valsartan/HCTZ products
  • Teva Pharmaceuticals Industries Ltd. valsartan/HCTZ products

The medications involved in the recall are Diovan, Diovan HCT, Exforge, Exforge HCT and Entresto.


NDMA Causing Cancer

However, the long-term risks posed by the NDMA found in certain valsartan-containing drugs remains unclear. NDMA is an organic chemical that forms in both industrial and natural processes. It has been used to make liquid rocket fuel, softeners, and lubricants, among other products. According to the U.S. Environmental Protection Agency, exposure to high levels of NDMA could cause liver damage.


Seek Justice

CancerMany people after taking valsartan medications like Diovan, Diovan HCT, Exforge, Exforge HCT and Entresto are horrified to learn that their medication could have caused their liver cancer. Therefore, it is important to seek justice. These potentially cancer-causing drugs have been on the market for over 5 years. This is unacceptable. You should hold these manufacturers accountable.
We want to help send a message that this is not acceptable. If a dangerous product harmed you, we will be your advocate. Additionally, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.

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