PhotoMylan Pharmaceuticals is recalling select lots of Valsartan-containing products, used in the treatment of high bloodpressure.

The products contain trace amounts of an impurity, N-nitrosodiethylamine, which has been classified as a probable human carcinogen.

The following batches of products, distributed in the U.S. between March 2017, and November 2018, are being recalled:

NDCProduct DescriptionStrengthSizeLot NumberExpiry
0378-1721-93Amlodipine and Valsartan Tablets, USP5mg/160mgBottles of 3030660513/2019
0378-1722-93Amlodipine and Valsartan Tablets, USP10mg/160mgBottles of 3030795001/2020
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg/320mgBottles of 30306198611/2018
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg/320mgBottles of 3030797091/2020
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg/320mgBottles of 30307761811/2019
0378-1724-93Amlodipine and Valsartan Tablets, USP10mg/320mgBottles of 3030797081/2020
0378-5813-77Valsartan Tablets, USP80mgBottles of 9030637821/2019
0378-5814-77Valsartan Tablets, USP160mgBottles of 9030713527/2019
0378-5807-93Valsartan Tablets, USP40mgBottles of 30306116911/2018
0378-5815-77Valsartan Tablets, USP320mgBottles of 9030814993/2020
0378-5815-77Valsartan Tablets, USP320mgBottles of 9030800092/2020
0378-5815-77Valsartan Tablets, USP320mgBottles of 9030800102/2020
0378-5815-77Valsartan Tablets, USP320mgBottles of 9030792051/2020
0378-6325-05Valsartan and Hydrochlorothiazide Tablets, USP320mg/25mgBottles of 50030848862/2019
0378-6325-05Valsartan and Hydrochlorothiazide Tablets, USP320mg/25mgBottles of 500309380412/2019

What to do

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

Consumers in possession of recalled product should contact Stericycle at (888) 406-9305 Monday through Friday 8 a.m. – 5 p.m. (EST) for the return of the recalled product.


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