Arthritis Drug Recalled After Glass Particles Found in Injection Vials

Distributors have also been instructed to notify customers who received or may have received the medication.

Published: 8/11/2026, 3:11:18 PM EDT

Arthritis Drug Recalled After Glass Particles Found in Injection Vials — The Food and Drug Administration in White Oak, Md., on June 5, 2023. The FDA is currently studying the safety of mifepristone. (Madalina Vasiliu/The Epoch Times)

A nationwide recall has been issued for a lot of the arthritis medication Tyenne after glass particles were discovered in some injection vials, posing a risk of blood clots, organ damage, or death, according to a company recall posted Tuesday by the U.S. Food and Drug Administration (FDA).

Fresenius Kabi, the manufacturer, began the recall after an internal investigation found glass particles in the product. The company is notifying distributors and customers by letter and arranging for the affected vials to be returned.

The recall applies to Tyenne 400 mg/20 mL vials from lot number 16UI07, with an expiration date of August 2028. The medication was distributed nationwide to wholesalers, distributors, and direct customers between March 3 and March 25.

“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,” the recall states.

A pulmonary embolism occurs when a blood clot blocks blood flow to the lungs. Less serious effects from glass particles may include pain, swelling, or irritation where the medication enters the body, as well as inflammation of the veins.

Health care facilities should immediately stop distributing, dispensing, or using vials from the recalled lot. Distributors have also been instructed to notify customers who received or may have received the medication.

Tyenne, also known as tocilizumab-aazg, is used to control inflammation associated with several serious health conditions. It is prescribed for adults with moderate to severe rheumatoid arthritis when certain other medications have not worked well enough.

Rheumatoid arthritis is a long-term autoimmune disease. It develops when the immune system mistakenly attacks healthy tissue, often causing painful, swollen, and stiff joints, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Tyenne is also used to treat giant cell arteritis, an inflammation of blood vessels, and certain forms of juvenile arthritis in children ages 2 and older. Other uses include treating severe immune reactions associated with CAR T-cell cancer therapy and certain adults hospitalized with COVID-19.

“Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product,” the recall states.

Consumers with questions about the recall can contact Fresenius Kabi USA Quality Assurance can be reached at 1-866-716-2459 from 8 a.m. to 5 p.m. Central time Monday through Friday. Suspected reactions or product problems may also be submitted through the FDA’s MedWatch program.