Drug Safety Alerts

Irbesartan Voluntary Recall

10/12/2021

On October 12, 2021, Lupin Pharmaceuticals, Inc. issued consumer-level recalls of Irbesartan tablets and Irbesartan/Hydrochlorothiazide tablets. These recalls were issued because analysis revealed that certain tested API batches were above the specification limit for N-nitrosoirbesartan impurity. Out of an abundance of caution, these drug product lots are being recalled.

This may represent a potential health hazard or safety risk to patients using product affected by these recalls.

A complete list of the affected products and lot numbers can be found here.

N-nitrosoirbesartan is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria.

Irbesartan/hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Lupin has advised that patients should continue taking their medication until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Irbesartan tablets and Irbesartan/Hydrochlorothiazide tablets to contact their prescriber.

For more information about the Irbesartan tablets and Irbesartan/Hydrochlorothiazide tablets, please call Lupin Pharmaceuticals toll-free at 1-866-587-4617. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.