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.

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — drug enforcement reference
Source observed: 9/2/2026, 12:00:00 AM UTC
Source updated: 9/2/2026, 12:00:00 AM UTC
Location: Lake Zurich, IL, US
hazard: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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.
distribution: Nationwide in the USA
manufacturer: Fresenius Kabi USA, LLC
recall number: D-0827-2026
source status: Ongoing
classification: Class I
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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