Teva Pharmaceuticals recently announced an amlodipine valsartan recall, making them the latest in the series of manufacturers to do so.

Several lots from the manufacturing company are involved in the recall, with the full list included in the U.S. Food and Drug Administration (FDA) press release. The recall includes a variety of amlodipine valsartan tablets and amlodipine valsartan hydrochlorothiazide tablets.

The issue stems from an impurity introduced to the valsartan ingredient during the manufacturing process. Valsartan manufactured by Mylan India has been shown to contain an impurity known as N-nitroso-diethylamine (NDMA). NDMA is a probable human carcinogen which is typically found in small amounts in some foods, drinking water, air pollution, and as a result of certain industrial processes.

“Patient safety and product quality is critical to Teva,” the company said through the FDA amlodipine valsartan announcement. “As always, Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.”

Teva Pharmaceuticals has reportedly notified its distributors and customers by certified mail. The company is also planning to arrange returns and reimbursements for returned products involved in the amlodipine valsartan recall.

Distributors of the affected medications have been instructed to stop all distribution of recalled valsartan and to quarantine any quantities remaining in their control.

The valsartan recall began in August when the FDA announced that three manufacturers would be recalling certain valsartan products due to the NDEA impurity. The federal agency is currently working with companies to determine the amount of NDMA in the valsartan medication and what risk patients may face. However, the tainted medications may have been on the market for years, meaning that consumers who have been taking valsartan for years may have been unknowingly exposing themselves to a carcinogen.

Even before the recalls were announced, many patients taking valsartan struggled with the drug’s potential for liver damage. After lab work showed elevated liver chemistries, some patients were forced to stop taking the drug which seemed to reduce the signs of liver toxicity. Additionally, patients have reported symptoms including jaundice, abdominal pain, hepatomegaly (enlargement of the liver), nausea, and pruritic erythematous skin changes.

Amlodipine valsartan medications are used to treat high blood pressure, heart failure, and heart attack patients. Valsartan medications are known as angiotensin II receptor agonists which work to treat conditions by reducing the constriction of blood vessels which allows blood to flow more freely. This mechanism effectively treats high blood pressure, a condition which can have a wide variety of side effects.

Because the medications deal with cardiac health, patients who are taking the affected medications should consult with their doctor and pharmacist to find a workable alternative. These consumers should not stop taking their medication without supervision from a doctor.

“The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment,” the FDA warns in the announcement.