FDA Drugs recall ·
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0827-2026
- Date
- (initiated August 10, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4,643 20mL-vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 16UI07, Exp 08/31/2028
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0827-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.