Blood Pressure Medication Recall 2021: Hypertension Drug Recalled Over Cancer Risks

In another recall over cancer-causing impurity levels, Lupin Pharmaceutical has recalled several batches of its Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets because N-nitrosoirbesartan – a substance that causes cancer - was found in levels above allowable specification limits.

The drugmaker received four reports of illness from Irbesartan and zero reports from the Irbesartan and Hydrochlorothiazide medication from the dates of Oct. 8, 2018 to Sept. 20, 2021.

However, Lupin said that it has received no reports of illness that appear related to the recall issue but is recalling the medication “out of an abundance of caution.”

The company is recalling all batches of 75 mg, 150 mg, and 300 mg of Irbesartan tablets and 150/12.5 mg and 300 mg/12.5 mg Irbesartan and Hydrochlorothiazide tablets in the U.S.

Irbesartan is used for the treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertension patients with Type 2 diabetes, an elevated serum creatinine, and proteinuria.

The Irbesartan medication was sold in 30 and 90 count bottles and distributed nationwide to drug chains, mail-order pharmacies, supermarkets, and wholesalers. A full list of recalled Irbesartan tablets can be viewed here.

Irbesartan and Hydrochlorothiazide medication is used to treat hypertension in patients who need multiple drugs to achieve their blood pressure goals or for hypertension management not adequately controlled with monotherapy.

The affected drug was sold in 30 and 90 count bottles nationwide to drug chains, mail-order pharmacies, supermarkets, and wholesalers. A full list of Irbesartan and Hydrochlorothiazide tablets recalled can be viewed here.

Patients who are taking the recalled medication are advised to continue taking the Irbesartan and Irbesartan and Hydrochlorothiazide tablets. They should contact their pharmacist or healthcare provider for an alternative treatment option.

Questions about the recall can be directed to Inmar Rx Solutions Inc. at 1-855-769-3988/1-855-769-3989, Monday through Friday, from 9 a.m. to 5 p.m. ET.

For reimbursement of the affected medication, the recalled lots can be returned to Inmar Rx Solutions, Inc. at 635 Vine St, Winston Salem, NC 27101. The lot number can be found on the side of the bottle label.

Lupin has discontinued marketing both medications as of Jan. 7, 2021.