Class I

Drug Recall: 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.

Fresenius Kabi USA, LLC · August 10, 2026

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

4,643 20mL-vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0827-2026

Status: ongoing

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Fresenius Kabi USA, LLC Drug Recall: 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. | SafeCheck