Tyenne Recalled

On Aug. 10, 2026, Fresenius Kabi initiated a voluntary recall of Tyenne^® (tocilizumab-aazg) Injection, 400mg/20mL (20mg/mL), 20mL vials. The recall was prompted by the presence of glass particles identified during an internal investigation, which may cause local irritation, pain, or swelling at the infusion site and inflammation of the veins, and more seriously may lead to vessel blockage and clotting that can cut off blood flow to vital organs, cause a life-threatening pulmonary embolism, or result in permanent organ damage or death. Tyenne is FDA-approved for the treatment of adults with moderately to severely active rheumatoid arthritis with inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adults with giant cell arteritis; patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis; patients 2 years and older with active systemic juvenile idiopathic arthritis; and adults and pediatric patients 2 years and older with chimeric antigen receptor (CAR) T cell–induced severe or life-threatening cytokine release syndrome and certain hospitalized adults with COVID-19. For more information about this recall, see here.