Lupin has received no reports of illness that appear to relate to this issue but is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US out of an abundance of caution,
Lupin advises patients who are prescribed the drugs to continue taking their medication and contact their pharmacist, physician, or medical provider for advice "regarding an alternative treatment."
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.
Adverse reactions or quality problems experienced with this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.