Lupin Pharmaceuticals is voluntarily recalling all lots of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level due to the presence of N-nitroso-irbesartan, a probable human carcinogen, above the Food and Drug Administration (FDA)’s acceptable daily intake limit.
Irbesartan is an angiotensin II receptor blocker indicated for the treatment of hypertension. It is also indicated for the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes and proteinuria. Irbesartan and Hydrochlorothiazide is indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs.
The affected lots of Irbesartan Tablets 75mg, 150mg, and 300mg, were distributed nationwide in the US between October 20, 2018 and December 3, 2020; the affected lots of Irbesartan and Hydrochlorothiazide Tablets 150mg/12.5mg and 300mg/12.5mg were distributed nationwide in the US between October 17, 2018 and November 18, 2020. The affected products are packaged in 30- and 90-count bottles. The full list of recalled products can be found here.
Since October 2018, the Company has received 4 reports of illness associated with Irbesartan and no reports associated with Irbesartan and Hydrochlorothiazide; however, none of these reports appear to be related to the recall issue.
Consumers, wholesalers, distributors, and retailers with any questions related to the recall should contact Inmar Rx Solutions at (855) 769-3988 or (855) 769-3989.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Lupin Pharmaceuticals, Inc. issues voluntarily nationwide recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets due to potential presence of N-nitrosoirbesartan impurity. News release. Lupin Pharmaceuticals, Inc. Accessed October 14, 2021. https://www.prnewswire.com/news-releases/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-of-all-irbesartan-tablets-and-irbesartan-and-hydrochlorothiazide-tablets-due-to-potential-presence-of-n-nitrosoirbesartan-impurity-301400273.html.