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Medication Safety Alerts

Aurobindo Pharma Amlodipine and Valsartan tablets, Valsartan and Hydrochlorothiazide Tablets and Valsartan Tablets Voluntary Recall

December 31, 2018

On December 31, 2018, Aurobindo Pharma issued a voluntary recall of amlodipine and valsartan tablets, valsartan and hydrochlorothiazide tablets and valsartan tablets. This recall was 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 and lot numbers is providedhere:

If your product was dispensed in the manufacturer’s bottle, please check the lot number. The lot number is on the manufacturer’s label. If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots or if your product was dispensed in a pharmacy’s vial, please contact the pharmacy that filled your prescription for more information including return instructions.

Please note: Because amlodipine and valsartan tablets, valsartan and hydrochlorothiazide tablets and valsartan tablets are used 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.

CVS Caremark Response: If you are currently taking amlodipine and valsartan tablets, valsartan and hydrochlorothiazide tablets and valsartan 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.

For more information regarding this recall, please call your doctor or call Aurobindo Pharma Inc. toll-free at 1-866-850-2876. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.

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