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# Lupin Pharma Recalls Irbesartan Over Impurity
- URL: https://www.fdaweb.com/lupin-pharma-recalls-irbesartan-over-impurity/
- Published: 2021-10-15T12:00:00.000Z
- Updated: 2026-09-14T17:19:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150376

Lupin Pharmaceuticals has recalled all irbesartan and irbesartan/hydrochlorothiazide tablets after an analysis revealed that certain active pharmaceutical ingredient batches were above the specification limit for the impurity N-nitrosoirbesartan. Irbesartan is an angiotensin II receptor blocker indicated for treating hypertension, and diabetic nephropathy in hypertensive patients with Type 2 diabetes. According to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan?ref=fdaweb.com), Lupin discontinued the marketing of the affected products in January.