Tyenne Injection Recalled Due to the Presence of Particulate Matter

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for Tyenne (tocilizumab-aazg) injection, 20 mg/mL. The affected batch has been identified as Lot 16UI07 (expires August 2028), containing 4643 vials.
• The recall was initiated by Fresenius Kabi USA, LLC due to the presence of particulate matter, a quality issue that is likely to cause serious adverse health consequences or death.
• Tocilizumab is used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, and juvenile idiopathic polyarthritis.

The FDA has issued a Class I recall for Tyenne (tocilizumab-aazg) injection, 20 mg/mL, affecting 4643 vials. This product is manufactured and is being recalled by Fresenius Kabi USA, LLC based in Lake Zurich, Illinois. The recall was initiated on August 10, 2026, and received a Class I classification on September 1, 2026. A Class I classification means the use of this product is likely to cause serious adverse health consequences or death.

The recall was initiated due to the presence of particulate matter, specifically glass particles, in the product. This deficiency affects Lot 16UI07, which will expire in August 2028. Fresenius Kabi USA sent out public notices via email, fax, letter, telephone, and personal visit; a press release was issued on August 10, 2026.

Tocilizumab is used to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat systemic juvenile idiopathic arthritis and juvenile idiopathic polyarthritis. Pharmacists should identify and quarantine Lot 16UI07, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 2, 2026. Accessed September 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221942