Tyenne recall (Fresenius Kabi USA, LLC)
DrugClass IOngoing
Summary: Fresenius Kabi USA, LLC is recalling 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.. Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What is being recalled
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.
Why
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot: 16UI07, Exp 08/31/2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0827-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | August 10, 2026 |
| Reported | September 2, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | Lake Zurich, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,643 20mL-vials |
More recalls from Fresenius Kabi USA, LLC · all drug recalls · recalls from August 2026