Solco Healthcare recalls Valsartan and Valsartan HCTZ tablets

Photo source: FDA

The products contain a trace amount of an unexpected impurity

Solco Healthcare is recalling all lots of Valsartan tablets and Valsartan-Hydrochlorothiazide tablets, which are used for treatment of hypertension, or high blood pressure.

A trace amount of an unexpected impurity -- N-nitrosodimethylamine (NDMA) -- was detected. NDMA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The company has received no reports of adverse events related to this recall.

The following products, with expiry dates from Jul 18 to Jan 20, are being recalled for all lots:

ProductNDC CodeDistribution Date
VALSARTAN TABLETS 40MG 30CT43547-367-03Oct 2015 – Jun 2018
VALSARTAN TABLETS 80MG 90CT43547-368-09Oct 2015 – Jun 2018
VALSARTAN TABLETS 160MG 90CT43547-369-09Oct 2015 – Jun 2018
VALSARTAN TABLETS 320MG 90CT43547-370-09Oct 2015 – Jun 2018
VALSARTAN/HCTZ 80MG/12.5MG 90CT TABLETS43547-311-09Jun 2016 – Jun 2018
VALSARTAN/HCTZ 160MG/12.5MG 90CT TABLETS43547-312-09Jun 2016 – Jun 2018
VALSARTAN/HCTZ 160MG/25MG 90CT TABLETS43547-313-09Jun 2016 – Jun 2018
VALSARTAN/HCTZ 320MG/12.5MG 90CT TABLETS43547-314-09Jun 2016 – Jun 2018
VALSARTAN/HCTZ 320MG/25MG 90CT TABLETS43547-315-09Jun 2016 – Jun 2018

What to do

Solco is notifying customers by letter and email and is arranging for return of all recalled products.

Consumers with questions may contact the company at (866) 931-9829, option 5, Monday through Friday, 9:00 a.m. – 5:00 p.m. (EST), or by email at

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