FDA: Fresenius Kabi Issues Nationwide Recall of Tyenne® (Tocilizumab-aazg) Injection 400mg/20mL Vials Due to Presence of Glass

Published: 08/12/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Rural Emergency Hospitals,
  • Assisted Living,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care,
  • Pharmacy,
  • Rural Health Clinics

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 contain glass particles.

  • Tyenne® (tocilizumab-aazg) Injection is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (D

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