Fresenius Kabi has issued a nationwide recall of one lot of Tyenne, or tocilizumab-aazg, Injection 400 mg/20 mL after an internal investigation found glass particles in the injectable product.
The recall affects Tyenne 400 mg/20 mL, or 20 mg/mL, supplied in 20 mL vials. The recalled product carries NDC number 65219-594-20, product code 590120, lot number 16UI07 and an expiration date of August 2028.
The affected lot was distributed nationwide to wholesalers, distributors and direct customers between March 3 and March 25, 2026. Fresenius Kabi is conducting the recall to the user level and said it is notifying distributors and customers by letter while arranging product returns.
The company warned that administration of an injectable drug containing glass particles can cause local irritation, pain or swelling at the infusion site, as well as inflammation of the veins. More serious risks include blood-vessel blockage and clotting, which may restrict blood flow to vital organs, cause pulmonary embolism, lead to permanent organ damage or result in death.
Tyenne is indicated for several inflammatory and immune-related conditions. These include moderately to severely active rheumatoid arthritis in adults with an inadequate response to disease-modifying antirheumatic drugs, giant cell arteritis in adults, and active polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis in patients ages 2 and older.
The product is also approved for adults and children ages 2 and older experiencing severe or life-threatening cytokine release syndrome induced by CAR T-cell therapy, as well as certain hospitalized adults with COVID-19.
Health care facilities with inventory from the recalled lot should immediately stop distributing, dispensing or using it and return all units to Fresenius Kabi, the company said. Distributors have been directed to notify customers who received or may have received the affected product.
Patients who believe they may have experienced a problem associated with Tyenne should contact their physician or health care provider. Fresenius Kabi said adverse reactions and product-quality concerns may be reported to its medical affairs or vigilance departments and to FDA’s MedWatch reporting program.
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