Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg/20 mL injection vials over glass particles
An internal investigation at the company found glass particles in vials of this injection, so the product contains particulate matter.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Fresenius Kabi USA, LLC
- Hazard
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Units
- 4,643 20mL-vials
- Where sold
- Nationwide in the USA
- FDA classification
- Class I · Ongoing
- Classified by FDA
- September 1, 2026
- Recall started
- August 10, 2026
- FDA enforcement report
- September 2, 2026
- Identifiers
- Codes: Lot: 16UI07, Exp 08/31/2028
- FDA recall number: D-0827-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class I (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 4,643 20mL-vials
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