FDA-PR2026-08-10PACKAGING DEFECT
Fresenius Kabi Tyenne tocilizumab injection recalled for glass particles
What this means
Fresenius Kabi recalled one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after discovering the product contains glass particles. The affected lot was distributed nationwide to hospitals, clinics, and distributors.
- If you are a healthcare facility with the affected lot (16UI07, expiration 08/2028), stop using it immediately and return all units to Fresenius Kabi.
- If you received this medication, contact your doctor or pharmacist to confirm whether you have the recalled lot.
- Report any symptoms such as pain, swelling, or inflammation at the infusion site to your healthcare provider immediately.
- Call Fresenius Kabi Quality Assurance at 1-866-716-2459 (Mon–Fri, 8 a.m.–5 p.m. CST) with questions about the recall.
Product photos
The agency's original wording
Hazard
FOR IMMEDIATE RELEASE – August 10, 2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to cont
Intended for
All ages (2 years and older)
Illnesses reported
None reported
Official notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-nationwide-recall-tyenner-tocilizumab-aazg-injection-400-mg20-ml-vials-dueMore Fresenius Kabi recalls
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