Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,
Recalled September 2, 2026 · FDA recall D-0827-2026 · Fresenius Kabi USA
Hazard
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. · FDA Class I
Units
4,643 20mL-vials
Sold at
Nationwide in the USA
Description
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →