FDA-Drug2026-09-02Class IPACKAGING DEFECT
Fresenius Kabi Tyenne tocilizumab injection recalled for glass particles
What this means
Fresenius Kabi USA discovered that Tyenne (tocilizumab-aazg) Injection vials may contain glass particles. The contamination was found during an internal investigation. The affected lot is 16UI07, which expires August 31, 2028.
- If you have received this medication, do not use it.
- Contact your healthcare provider or pharmacist immediately for a replacement.
- Check your vials for any visible particles before use.
The agency's original wording
Hazard
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
4,643 20mL-vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2026More Fresenius Kabi recalls
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