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DRUG RECALLCRITICAL
Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL
Fresenius Kabi recalls Tyenne ( (tocilizumab-aazg) 400 mg/20 mL vials over glass particles.
What to do
Consumers with the affected product should stop using it immediately and contact their healthcare provider or pharmacist for guidance.
Recall at a glance
- Quantity recalled
- 4,643 20mL-vials
Why it was recalled
Fresenius Kabi is recalling Tyenne ( (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vials, because an internal investigation found glass particles in the product.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Tyenne (tocilizumab-aazg) Injection
- Lot code
- 16UI07, 2028
- Strength
- 400 mg
- NDC / UPC
- NDC 65219-594-20
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Foreign Material recalls
Other recent recalls from Fresenius Kabi USA, LLC
Editorial summary by Recall Canary · summary updated 2026-09-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification