The FDA has announced that Lupin Pharmaceuticals is recalling multiple lots of two different medications, irbesartan tablets and irbesartan and hydrochlorothiazide tablets, used to treat hypertension. The reason for the recall is the potential presence of unacceptable levels of N-nitrosoirbesartan, a contaminant associated with cancer. At this time, there have been no reports of illness related to this issue.
Irbesartan is an angiotensin II receptor blocker used to treat hypertension and diabetic nephropathy. The affected batches were originally distributed from October 2018 to December 2020.
Irbesartan and hydrochlorothiazide, meanwhile, includes an additional thiazide diuretic and is often used to treat hypertension patients who are expected to need multiple medications. The affected batches were originally distributed from October 2018 to November 2020.
According to the FDA, any patients taking these medications should “continue taking their medication and contact their pharmacist, physician or medical provider for advice regarding an alternative treatment.”
Distributors and retailers, on the other hand, have been asked to stop selling the medications and immediately work toward returning them.
Read the full FDA advisory here.