Fresenius Kabi has issued a nationwide recall of one lot of Tyenne (tocilizumab-aazg) injection after finding glass particles in the vials.
Announced in mid-August 2026, the recall covers Tyenne 400 mg/20 mL single-lot vials — lot 16UI07, with an expiration date of August 2028 — down to the user level. Tyenne is a biosimilar of tocilizumab, an interleukin-6 (IL-6) blocker used to treat rheumatoid arthritis and other inflammatory conditions. The affected product was distributed nationwide to wholesalers, distributors and direct customers between March 3 and March 25.
The risk
According to the company, injecting a product that contains glass particulates could cause local irritation, pain or swelling at the infusion site, as well as inflammation of the veins (phlebitis). An internal investigation identified the glass particles.
What to do
Fresenius Kabi is notifying distributors and customers by letter and arranging returns of the recalled product. Patients or providers with the affected lot should stop using it and follow the return instructions; questions can go to Fresenius Kabi USA Quality Assurance at 1-866-716-2459 (Mon–Fri, 8 a.m.–5 p.m. Central). Patients with concerns about their treatment should contact their healthcare provider.
This is a product-safety notice, not medical advice. If you use this medication, do not change your treatment on your own — contact your healthcare provider.