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2 blood pressure drugs recalled because of concern about cancer-causing ingredient

The FDA has released sample labels of some of the two recalled blood pressure medications — various dosages of irbesartan tablets and irbesartan and hydrochlorothiazide tablets.
The FDA has released sample labels of some of the two recalled blood pressure medications — various dosages of irbesartan tablets and irbesartan and hydrochlorothiazide tablets.

Two types of blood pressure medication made by the company Lupin Pharmaceuticals are being recalled because they may contain high levels of a substance that could cause cancer.

The Food and Drug Administration said late last week that Lupin is voluntarily recalling certain dosages of irbesartan tablets and irbesartan and hydrochlorothiazide tablets. Both are used to treat hypertension, or high blood pressure, and were distributed in 30- and 90-count bottles nationwide.

The company found that certain batches of those drugs were "above the specification limit for the impurity N-nitrosoirbesartan," which could cause cancer in humans. It says it's received no reports of illness that appear to be related to this issue, but is acting out of an abundance of caution. It's recalling:

  • All batches of irbesartan tablets USP 75mg, 150mg and 300mg
  • All batches of irbesartan and hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg
  • Lupin says it received four reports of illness from irbesartan and none from irbesartan and hydrochlorothiazide between October 2018 (when the first of these affected batches were shipped from the manufacturing site) and the end of September 2021.It discontinued the marketing of both drugs in January of this year.

    Here's what to do

    Lupin advises patients prescribed the drugs to continue taking their medication and contact their pharmacist, physician or medical provider for advice "regarding an alternative treatment."

    The company says it's notifying wholesalers, distributors, drug chains, mail order pharmacies and supermarkets and arranging for the return of all the recalled product lots.

    Images of the product packaging can be found here.

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