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.

Recall Number: D-0827-2026

Firm: Fresenius Kabi USA, LLC

Classification: Class I

Status: Ongoing

Report Date: 20260902

Initiation Date: 20260810

Termination Date:

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

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.