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Recall: Certain valsartan-containing medications recalled due to impurity

Detection of an impurity has prompted the US Food and Drug Administration (FDA) to announce a voluntary recall of several medications containing the active ingredient valsartan.

Among the products recalled are valsartan-containing medications manufactured by Major Pharmaceuticals, Solco Healthcare and generics manufacturer Teva Pharmaceuticals Ltd. The affected products were found to contain n-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen. The FDA suggested the presence of the substance was related to changes in the manufacturing process of the active ingredient valsartan.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Valsartan is an active ingredient in medication used to treat hypertension (high blood pressure), heart failure, and to improve life expectancy following a heart attack. Drugs such as Diovan (valsartan) fall into the class of angiotensin-II receptor blockers (ARBs), which work by relaxing the blood vessels, allowing blood to flow more easily. 

What medications have been recalled? 

The companies below are recalling all non-expired products containing valsartan and supplied by the Zhejiang Huahai Pharmaceuticals, Linhai, China. 

          Valsartan  -  Major Pharmaceuticals

          Valsartan  -  Solco Healthcare

          Valsartan  -  Teva Pharmaceuticals Industries Ltd.

          Valsartan/ Hydrochlorothiazide (HCTZ)  -  Solco Healthcare

          Valsartan/ Hydrochlorothiazide (HCTZ)  -  Teva Pharmaceuticals Ltd.

How do I know if my medication has been recalled? 

Examine the drug name and the company name on the label of the prescription bottle. If you are still unsure, contact the pharmacy that dispensed the medication for more information. 

What to do if my medication is recalled? 

Continue taking your medication, even if your valsartan-containing medicine is among those recalled. Due to the severity of the conditions the drug is used to treat, the FDA urged patients not to stop taking their meds until a replacement product is acquired.

If your drugs are among those listed above, follow the recall instructions provided by each of the manufacturers. This information is provided on the FDA’s website. 

Contact your healthcare professional, for example, your pharmacist or physician, to discuss your treatment and whether another valsartan product or alternative treatment is necessary.