Recall D-0827-2026

US Class I Ongoing · initiated 2026-08-10

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

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.

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