Nationwide Recall Issued for Tyenne Injection Over Glass Contamination

Fresenius Kabi, an operating company of the Fresenius Group, has issued a nationwide recall of one lot of Tyenne (tocilizumab-aazg) Injection, 400 mg per 20 mL vials, after an internal investigation found glass particles present in the product.

Tyenne is a biologic medication used to treat a range of conditions, including moderately to severely active rheumatoid arthritis in patients who haven't responded adequately to standard disease-modifying antirheumatic drugs, giant cell arteritis, active polyarticular and systemic juvenile idiopathic arthritis in patients 2 years and older, cytokine release syndrome linked to CAR-T cell therapy, and certain hospitalized patients with COVID-19.

The risk of glass particles in an injectable drug

Administering an injectable medication that contains glass particulates carries serious risk. According to the recall notice, potential effects range from localized irritation, pain or swelling at the infusion site to more severe complications, including inflammation of the veins. In more serious cases, glass particles can cause blockages or clotting within blood vessels, potentially cutting off blood flow to vital organs. That can lead to a pulmonary embolism, a life-threatening blood clot in the lungs, as well as permanent organ damage or death.

Identifying the recalled product

The recall affects a single lot of Tyenne, identified by lot number 16UI07, with an NDC number of 65219-594-20 and an expiration date of August 2028. The affected product was first shipped March 3, 2026, and last shipped March 25, 2026, and was distributed nationwide to wholesalers, distributors and direct customers.

Health care facilities that have any units from this lot are instructed to immediately stop distributing, dispensing or using the product and to return all units to Fresenius Kabi. Distributors have been directed to notify any customers who received or may have received the affected lot.

What patients and providers should do

Fresenius Kabi is notifying distributors and customers directly by letter and coordinating the return of recalled units. Patients who have received this medication and experienced symptoms that could be related to the recall are advised to contact their physician or health care provider.

This recall affects a single, specifically identified lot of Tyenne rather than the medication broadly. Patients currently using Tyenne for rheumatoid arthritis or another approved condition should not stop treatment without first speaking with their provider, but should check whether their supply matches the recalled lot number and report any concerning symptoms promptly.

Consumers with questions about the recall can reach Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, 8 a.m. to 5 p.m. Central time. Adverse reactions or quality concerns related to the product can also be reported to Fresenius Kabi's Medical Affairs or Vigilance departments at 1-800-551-7176 or by email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.