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Class I · Most seriousActive recall

Tyenne

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot: 16UI07, Exp 08/31/2028
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi USA, LLC
Brand nameTYENNE
Generic nameTOCILIZUMAB-AAZG
Active ingredient(s)TOCILIZUMAB
Distributed by / forFresenius Kabi USA, LLC
NDC65219-594-20
Show the full FDA record
Full product labelTyenne (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.
Recalling firmFresenius Kabi USA, LLC
DistributionNationwide in the USA
Quantity4,643 20mL-vials
Recall initiated2026-08-10
Report date2026-09-02
Recall completed—
Recall numberD-0827-2026
ClassificationClass I
FDA statusOngoing
Origin on fileLake Zurich IL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.