FDA recall D-0827-2026

Fresenius Kabi USA, LLC · Class I · drug

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.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2026-08-10
Report date: 2026-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2026