Tyenne Injection 400 mg/20 mL vial

  • Due to Presence of Glass Particles
  • Company: Fresenius Kabi
  • Drugs
  • FDA
  • August 10, 2026

Product details

  • Tyenne Injection 400 mg/20 mL vial

Company announcement

Fresenius Kabi is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL vials nationwide, as announced on August 10, 2026, due to the presence of glass particles.

The product was distributed to wholesalers, distributors, and direct customers across the United States.

The document does not mention any reported deaths or injuries related to this recall.

Risk:

The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More seriously, glass particles can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death.

Impacted states: Nationwide

Products:

- Tyenne® (tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial

Contact

For more information, call (800) 551-7176 or email productcomplaint.USA@fresenius-kabi.com.

View the original FDA notice

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