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Medication Safety Alerts

Mylan Valsartan Products Voluntary Recall

November 20, 2018

On November 20, 2018, Mylan issued a voluntary recall of amlodipine and valsartan tablets, valsartan tablets and valsartan and hydrochlorothiazide tablets. On December 4, 2018, Mylan issued an expanded voluntary recall to include all lots. This recall were issued because an unexpected impurity was found in these products that may cause health risks.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of the affected products is provided here.

Please note: Because valsartan is used in medicines to treat serious medical conditions, the United States Food and Drug Administration (FDA) recommends that members should not stop their medicine until they receive replacement product or a different medicine to treat their condition. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please contact your doctor.

Please contact the pharmacy that filled your prescription for instructions regarding return and replacement of any affected product.

CVS Caremark Response: If you are currently taking amlodipine and valsartan tablets, valsartan tablets or valsartan and hydrochlorothiazide tablets, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking amlodipine and valsartan tablets, valsartan tablets or valsartan and hydrochlorothiazide tablets and have questions regarding this recall, please call your doctor or call Mylan Pharmaceuticals toll-free at 800.796.9526 800.796.9526 800.796.95261-800-796-9526 or visit http://newsroom.mylan.com.

You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.

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