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All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Recalled

On October 14, 2021, Lupin Pharmaceuticals announced its voluntary recall of all of Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets due to the presence of a probable human carcinogen. Analysis revealed that certain tested active pharmaceutical ingredient (API) batches — but not finished product batches — were above the specification limit for the impurity, N-nitrosoirbesartan.

Please review your patients’ progress on Irbesartan and discuss the risks of continued use, and other available treatments for them.

References: FDA MedWatch. Drug Safety Communication. Accessed October 18, 2021; Irbesartan prescribing information. Revised 2/2016.

Published on: November 1, 2021, 11:00 a.m. ET
Last updated on: October 29, 2021, 03:52 a.m. ET