Valsartan

July 2018: The first Valsartan recalls were instituted by the Food and Drug Administration (FDA) after the probable human carcinogen N-nitrosodimethylamine (NDMA) was discovered to have contaminated the popular blood pressure medication. The recalled Valsartan was supplied by the Chinese company, Zhejiang Huahai Pharmaceuticals. The NDMA contamination was found in the company’s manufacturing facility and it is believed that NDMA had been contaminating Zhejiang’s Valsartan products since 2012 when NDMA was produced as a by-product of changes in manufacturing processes.

The FDA sent an update to health care professionals and patients after discovering companies that repackage drug products were also recalling valsartan-containing products. There were three additional repackagers of products containing Valsartan made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc that recalled products due to NDMA contamination. The products were labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack.

August 2018: The FDA released an updated list of recalled Valsartan products after the announcement that manufacturer Hetero Labs Limited (located in India and labeled as Camber Pharmaceuticals Inc) was recalling certain Valsartan tablets due to the discovery of the NDMA in their active pharmaceutical ingredient (API). Test results from the Hetero Labs showed that the levels of NDMA found in the Valsartan API exceeded the threshold deemed safe by the FDA.

November 2018: The FDA issued an alert regarding Mylan Pharmaceuticals’ voluntary recall of 15 lots of Valsartan-containing products due to the presence of NDEA. Not all of Mylan’s Valsartan-containing products in the U.S. were recalled; only those that tested for NDEA above the levels deemed acceptable by the FDA were included in the recall.

The FDA issued an alert regarding Teva Pharmaceuticals’ voluntary recall of products containing Valsartan. Teva recalled all lots of amlodipine and Valsartan combination tablets and amlodipine, Valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to NDEA contamination.

December 2018: The Valsartan recall was expanded through pharmaceutical company Mylan’s voluntary recall of over 100 lots of Valsartan medications, including Amlodipine and Valsartan Tablets, Valsartan Tablets, and Hydrochlorothiazide Tablets.

January 2019: The FDA alerted patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of Valsartan tablets–26 lots of amlodipine and Valsartan combination tablets, and 52 lots of Valsartan and hydrochlorothiazide (HCTZ) combination tablets. The recall was due to the amount of NDEA found in the API.

March 2019: The FDA announced AurobindoPharma USA’s voluntary recall expansion to patients and health care providers. Aurobindo expanded the recall to include 38 additional lots of Valsartan and amlodipine/Valsartan combination tablets due to the presence of NDEA.