Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20… was recalled on August 10, 2026 in cooperation with the U.S. Food and Drug Administration because presence of particulate matter:An internal investigation at the firm found the product to contain glass particles..
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: 16UI07, Exp 08/31/2028
Units affected: 4,643 20mL-vials
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I is the most serious FDA recall level: using or being exposed to the product could cause serious health problems or death.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Fresenius Kabi USA, LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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