PhotoMajor Pharmaceuticals is recalling all lots Valsartan which was supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals and is used to treat hypertension (high blood pressure) and heart failure.

Trace amounts of an unexpected impurity -- N- nitrosodimethylamine (NDMA -- were found in an active pharmaceutical ingredient (API).

NDMA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The following product, distributed nationwide as unit dose blisters with 100 tablets per carton, is being recalled:

Product DescriptionNDC NumberItem NumberLot NumberExpiration Date
Valsartan 80mg Tablets, USP0904-6594-61302086T0179505/2019
T0180705/2019
T0171202/2019
T0162502/2019
T0159602/2019
T0150002/2019
T0146607/2018
T0127007/2018
Valsartan 160mg Tablets, USP00904-6595-61302087T0164605/2019
T0178805/2019
T0166805/2019
T0152402/2019
T0126907/2018

What to do

Consumers with questions regarding the recall may contact Major Pharmaceuticals customer support at (800) 616-2471, Option #1 Monday through Friday, 8 a.m. – 8 p.m. (EST).


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