Lupin Pharmaceuticals is recalling several batches of hypertension pills after an analysis found that some batches contained levels of a possible carcinogen higher than the FDA's acceptable limits.
The Baltimore-based drugmaker said Oct. 14 that it is recalling several lots of both irbesartan tablets and combination irbesartan and hydrochlorothiazide tablets after finding some batches containing higher than acceptable levels of N-nitrosoirbesartan.
N-nitrosoirbesartan is a probable human carcinogen, meaning a substance that could cause cancer.
Lupin said it has received four reports of illness from irbesartan and no reports of illness from combination irbesartan and hydrochlorothiazide between 2018 and 2021. But no reports of illness appear related to the presence of N-nitrosoirbesartan, the company said.
Lupin discontinued marketing both drugs in January.
Irebesartan is indicated to lower blood pressure, and combination irbesartan and hydrochlorothiazide is indicated to treat hypertension in patients whose condition can't be adequately treated with a single drug.
The recalled drugs were distributed nationwide to U.S. wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin said it is arranging for the return of all the recalled products. Patients are advised to continue taking the medication until they can speak to a provider for advice on an alternative treatment.
Azido impurities have also been found in blood pressure drugs recently. Canada and European countries have begun asking drugmakers to recall certain heart drugs after finding the impurities, which are chemicals that can change a person's DNA and potentially increase their cancer risk, though the U.S. has yet to pull the drugs.