Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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.
- Lot codes and dates
- Lot
16UI07Exp 08/31/2028
- Lot
- Amount recalled
- 4,643 20mL-vials
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Using this product could cause serious injury, illness or death — stop using it now.
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