Lupin's ongoing analysis of its API batches revealed some batches were above the specification limit for the impurity N-nitrosoirbesartan.

In the US, Lupin has received no reports of illness that relate to this issue. However, the company is recalling all batches of the following medication based on caution. The medications are:

  •  75mg, 150mg and 300mg of Irbesartan Tablets USP.
  • 150mg/12.5mg and 300 mg/12.5mg Irbesartan and Hydrochlorothiazide Tablets USP.

Laboratory tests indicate that N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer). From October 8, 2018, to September 30, 2021, Lupin received four reports of illnesses linked to Irbesartan and 0 reports related to both Hydrochlorothiazide and Irbesartan.

Irbesartan tablet USP - A angiotensin II receptor blocker used to treat hypertension, diabetic nephropathy, an elevated serum creatinine, low blood pressure in patients with hypertension and type II diabetes and proteinuria. The combination of irbesartan and hydrochlorothiazide tablet USP is indicated for hypertensive patients who do not respond adequately to monotherapy or patients who require multiple medications. Lupin Pharmaceuticals Inc. is notifying all of its wholesalers, drug chains, distributors, mail order pharmacies and supermarkets to return the recalled product lots.


Patients should continue to take their medications and speak with their pharmacist, physician, or healthcare provider to find out if an alternative treatment is available to them. The FDA's MedWatch Adverse Event Reporting program can be contacted by mail, fax or online if an adverse reaction or quality problem happens while using this product.


Disease condition,Hypertension



Disease Condition ,Hypertension