Hypertension Medication Recalled Due to Dissolution Failure

A Class II recall has been initiated for Irbesartan Tablets USP, 300 mg, manufactured for AvKARE in Pulaski, Tennessee. The recall affects 341 cartons of the product, each containing 50 tablets (5x10 unit dose per carton). The issue leading to the recall is out-of-specification dissolution results, which could impact the medication’s effectiveness. The affected lot is #45279, with an expiration date of March 31, 2025. The recall, initiated on January 21, 2025, remains ongoing, and the product was distributed nationwide. 

The recalling firm, AvKARE, has notified its consignees and relevant stakeholders via letter. The FDA classified the recall as Class II on February 11, 2025, indicating that use of the product may cause temporary or medically reversible health issues but is unlikely to lead to severe adverse effects. 

Irbesartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) and diabetic nephropathy in patients with type 2 diabetes. Poor dissolution could lead to reduced drug absorption, potentially compromising blood pressure control and increasing cardiovascular risks.