Recall of Valsartan, Amlodipine/Valsartan and Valsartan/Hydrochlorothiazide Tablets

On November 20, 2018, Mylan Pharmaceuticals announced a voluntary recall of 15 lots of Valsartan, Amlodipine/Valsartan and Valsartan/Hydrochlorothiazide Tablets. Valsartan is a drug used to treat high blood pressure and heart failure.

One maker of Valsartan, Amlodipine/Valsartan and Valsartan/Hydrochlorothiazide is recalling certain lots of these medicines because they may have small amounts of an ingredient which could cause cancer. Below is a list of medicines and makers involved in the recall.

Medicine Maker
Valsartan 40mg Tablets Mylan Pharmaceuticals
Valsartan 80mg Tablets
Valsartan 160mg Tablets
Valsartan 320mg Tablets
Amlodipine/Valsartan 5mg/160mg Tablets
Amlodipine/Valsartan 10mg/160mg Tablets
Amlodipine/Valsartan 10mg/320mg Tablets
Valsartan/Hydrochlorothiazide 320mg/25mg Tablets

What should you do?

  • Step 1: Look for the medicine and maker’s name on your prescription bottle label.
  • Step 2: Contact your pharmacy or doctor if you see the medicine and maker listed above. If you can’t find the information on the bottle, contact your pharmacy.
  • Step 3: Talk to your pharmacist or doctor about your treatment options. Do not stop taking the medicine without talking to your doctor.

We want to make sure you have the information you need to stay safe. Go to ? for more information on Valsartan, Amlodipine/Valsartan and Valsartan/Hydrochlorothiazide. You can also call the U.S. Food & Drug Administration (FDA) toll free at 1-888-INFO-FDA (1-888-463-6332) or the Horizon NJ Health Pharmacy Help Desk at 1-800-682-9094 (TTY 711) x81016.