October 20, 2021
N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure.
What is being recalled?
What do I need to know?
• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
You can also report adverse events or quality problems related to the use of the drug to the FDA’s MedWatch Adverse Events Reporting Program. Call 800.FDA.1088 or go to https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Last updated: October 20, 2021