FDAFDA · Food and drugs·Recall number D-0827-2026
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.
Published September 2, 2026 · Recall initiated: August 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- TYENNE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot: 16UI07, Exp 08/31/2028
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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