Recall of valsartan products made by three companies
The U.S. Food and Drug Administration has announced a recall of several drug products containing the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
Please note that not all drug products containing valsartan are being recalled.
Since valsartan is used in medicines to treat serious medical conditions, do not stop taking it if your prescription has been affected until you have a replacement product.
Below is a list of the products under recall and their manufacturers:
| Medicine | Manufacturer |
| Valsartan | Major Pharmaceuticals |
| Valsartan | Solco Healthcare |
| Valsartan | Teva Pharmaceuticals Industries Ltd. |
| Valsartan/Hydrochlorothiazide (HCTZ) | Solco Healthcare |
| Valsartan/Hydrochlorothiazide (HCTZ) | Teva Pharmaceuticals Industries Ltd. |
How do I determine if my valsartan prescription is on the recall list?
- To determine whether the medicine you are taking is part of the recall, look at the drug name and company name on the label of your prescription bottle. If the information is not clearly identified, contact the pharmacy that filled the prescription. They can let you know if you are taking one of the recalled products.
- If the manufacturer on your prescription label is NOT one of the three companies above, then your medicine is NOT involved in the recall and you may continue to take that product.
What do I do if I am taking a medicine from one of the above companies that contains valsartan?
- If you find that you are taking one of the recalled products, contact the pharmacy that filled your prescription and ask if they can refill your prescription with valsartan from another company not affected by the recall.
- If another company’s valsartan is not available, ask about other treatment options. They can call the physician who prescribed the medication to discuss a substitute. Do not stop taking your medicine. Continue taking your medicine as prescribed until a replacement is identified.
Why are these products being recalled?
The recalled products were found to contain an impurity – N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. However, not all products containing valsartan are being recalled.
Whom do I contact with additional questions or for more information?
- You should start by contacting the pharmacy that filled your prescription of valsartan and speak with a pharmacist.
- You may also wish to visit the FDA’s website for additional information, instructions by the manufacturers and their contact information.
- The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and healthcare professionals to report any adverse reaction to the FDA’s MedWatch program.