Fresenius Kabi recalls Tyenne arthritis injection due to glass particles

Fresenius Kabi has issued a nationwide recall for one lot of Tyenne (tocilizumab-aazg) injection, a medication used to treat rheumatoid arthritis and other inflammatory conditions. The recall was initiated after an internal investigation discovered glass particles within the vials.

The affected product is the 400 mg/20 mL injection, specifically lot number 16UI07 (National Drug Code 65219-594-20) with an expiration date of August 2028. These vials were shipped between March 3 and March 25, 2026, and distributed to wholesalers, distributors, and direct customers across the United States.

Because Tyenne is administered intravenously in clinics and hospitals, the presence of glass particles poses significant health risks. Potential complications include local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More severe risks include blood vessel blockage and clotting, which could lead to life-threatening pulmonary embolisms, permanent organ damage, or death.

Healthcare providers are instructed to immediately stop distributing, dispensing, or using the affected lot. The recall is being conducted at the user level, requiring hospitals and infusion centers to return the product.