Tyenne arthritis medication recall

Fresenius Kabi has initiated a nationwide recall in the United States for a specific lot of Tyenne (tocilizumab-aazg) 400 mg/20 mL vials. The recall follows an internal investigation that identified the presence of glass particles within the medication, which is used to treat moderate to severe rheumatoid arthritis and other inflammatory conditions.

The affected product is lot number 16UI07, which has an expiration date of August 2028. These vials were distributed to wholesalers, distributors, and direct customers between March 3 and March 25, 2026.

The U.S. Food and Drug Administration (FDA) and the manufacturer have warned that the contamination poses severe health risks. Because the medication is administered intravenously, glass particles could cause local irritation, pain, or swelling at the infusion site, as well as vein inflammation. More critical risks include blood vessel blockages and clotting, which may result in permanent organ damage, life-threatening pulmonary embolisms, or death. Healthcare providers have been instructed to immediately cease the distribution, dispensing, or use of the affected lot.