Irbesartan Recalled Due to Cancer-Causing Impurity

October 25, 2021

Last week, Lupin Pharmaceuticals voluntarily recalled two types of blood pressure medication because they may have high levels of an impurity that may cause cancer.

The recall includes all irbesartan tablets, including 75 milligram (mg), 150 mg and 300 mg tablets. The recall also includes all batches of irbesartan plus hydrochlorothiazide tablets (150 mg/12.5 mg and 300 mg/12.5 mg).

These drugs are used to treat high blood pressure and were being distributed in 30 and 90-count bottles across the nation. Irbesartan was also prescribed to treat diabetic nephropathy in patients with type 2 diabetes who also have high blood pressure and elevated proteinuria and serum creatinine.

Lupin chose to do the recall out of an abundance of caution. The company said it has not received any reports of illness related to the impurity (N-nitrosoirbesartan). Although the pills were still on the market before the recall, Lupin had stopped marketing the drugs in January. This came after the company received four reports of illness among those taking irbesartan between October 2018 and September 2021.

If you are currently taking one of these medications, the U.S. Food and Drug Administration (FDA) says you should keep taking it and talk to your doctor or pharmacist for advice on an alternative medication to treat high blood pressure. Adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting Program. This can be done via the website or fax or regular mail.

Lupin is in contact with wholesalers, distributors, drug chains, mail order pharmacies and supermarkets to arrange for the remaining pills to be returned to the manufacturer.

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