OVERLOOKED

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Class IOngoing

Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Fresenius Kabi USA, LLC
Reason
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Nationwide in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99603…

Products

  1. 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.

    Codes/lots: Lot: 16UI07, Exp 08/31/2028Quantity: 4,643 20mL-vialsRecall no. D-0827-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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