Recall - Fresenius Kabi (Tyenne Injection 400 mg/20 mL vial) produced by Fresenius Kabi - Due to Presence of Glass Particles

Summary

Company Announcement

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 contain glass particles.

Risk Statement: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.

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 (DMARDs); adult patients with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; patients 2 years of age and older with active systemic juvenile idiopathic arthritis; adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and certain hospitalized adult patients with COVID-19.

Recalled product can be identified as follows (with label below):

Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL was distributed nationwide to wholesalers, distributors and direct customers.

Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time or send an e-mail to either [email protected] or [email protected].

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.