FDA-PR2026-08-10PACKAGING DEFECT

Fresenius Kabi Tyenne tocilizumab injection recalled for glass particles

GLASSNationwide distribution

Fresenius Kabi Tyenne injection recalled for glass particles

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

Tyenne Injection 400 mg/20 mL (20 mg/mL)
Tyenne Injection 400 mg/20 mL (20 mg/mL)
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

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-due

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