Class IDrugOngoing

Fresenius Kabi USA, LLC

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

Reason for recall

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Details

Recall number: D-0827-2026
Event ID: 99603
Recall initiated: Aug 10, 2026
Classified: Sep 1, 2026
Reported: Sep 2, 2026
Quantity: 4,643 20mL-vials
Distribution: Nationwide in the USA
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Lake Zurich, IL, United States
Lot / code info: Lot: 16UI07, Exp 08/31/2028