Recall of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP

On December 31, 2018, Aurobindo Pharma USA announced a voluntary nationwide recall of 80 lots of Amlodipine Valsartan tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP. Aurobindo Pharma USA recalled these medicines because they may have small amounts of an ingredient which could cause cancer. To date, no harmful side effects have been reported due to this recall. Below is a list of medicines and makers involved in the recall.

Medicine Maker
Amlodipine Valsartan Aurobindo Pharma
Valsartan HCTZ Aurobindo Pharma
Valsartan Aurobindo Pharma

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 a 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 take care of your health. For more information on Amlodipine Valsartan, Valsartan HCTZ and Valsartan, visit You can also call the U.S. Food & Drug Administration (FDA) toll free at 1-888-INFO-FDA (1-888-463-6332) or Horizon NJ Health Pharmacy Help Desk at 1-800-682-9094 (TTY 711) x81016, Monday through Friday 8 a.m. to 6:30 p.m. and Saturday 8 a.m. to 4:30 p.m., Eastern Time.