Several medications containing the blood pressure and heart failure drug, valsartan, were recalled in July due to concerns over contamination. At the time, the FDA announced that they found NDMA (N-nitrosodimethylamine), a possible cancer-causing substance, in the drugs. Since then, the FDA has expanded the list of recalled products to include about 80 different products across 16 manufacturers.
What is valsartan for?
Valsartan is a drug prescribed to treat high blood pressure and heart failure, and to reduce the risk of death in people with heart dysfunction after suffering a heart attack. It’s also used as therapy for certain people who are at risk for end-stage kidney disease.
Why were products recalled?
Certain valsartan products sold in the US have been recalled because an impurity, NMDA (N-nitrosodimethylamine), was discovered in related batches. NMDA is considered to be a probable cancer-causing agent. Its presence in the recalled valsartan drugs may be related to a change in the chemical reactions used during the manufacturing process.
Again, not all products containing valsartan have been recalled—only those that came from the manufacturers listed below who were supplied the active ingredient from Zhejiang Huahei Pharmaceuticals. The supplier has since stopped distributing the valsartan active ingredient, and the FDA is working with affected companies to keep NMDA out of future products.
Which products were recalled?
Valsartan-containing products from the following manufacturers have been recalled:
- Teva Pharmaceuticals labelled as Major Pharmaceuticals
- Teva Pharmaceuticals labelled as Actavis
- Prinston Pharmaceutical, Inc. labelled as Solco Healthcare, LLC
- Remedy Repack
- A-S Medication Solutions, LLC
- Bryant Ranch Prepack Inc.
- HJ Harkins Company, Inc. dba Pharma Pac
- Proficient Rx, LP
- Northwind Pharmaceuticals
- Camber Pharmaceuticals, Inc.
- NuCare Pharmaceuticals, Inc.
- Torrent Pharmaceuticals Limited
Specific product lots involved in the recall are listed on this FDA document, updated as of August 27, 2018.
To find out whether your specific product has been recalled, look for the drug name and company name on the label of your prescription bottle. If that information is not on the bottle, contact the pharmacy that dispensed it to you.
To help give consumers peace of mind, the FDA has also published this list of valsartan medications NOT currently being recalled, updated as of September 21, 2018.
What do I do if I think I have a recalled product?
- Do not stop taking your medication. If you were prescribed valsartan, it’s because you need it to treat a serious medical condition. Whether or not you think you have a recalled product, continue taking your medication until you have an effective replacement. Not all valsartan products were affected by this recall, and there are many other drugs that could work well as alternatives.
- Contact your doctor or pharmacist. Contact your health provider to discuss treatment options if you think you have a recalled valsartan product. Your next step might be taking a valsartan product not involved in this recall or using another medication equally effective for your health condition.
- Report issues to the manufacturer and FDA. Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. Contact information for manufacturers of recalled valsartan products are available in the links above. Any adverse reactions or quality problems can also be reported to the FDA’s MedWatch Reporting Program as they can conduct further investigations.
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