FDAFDA recall D-0827-2026 · Sep 2, 2026
Fresenius Kabi USA, LLC: Tyenne (tocilizumab-aazg) Injection recall
Recall found
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.
Reason for recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot: 16UI07, Exp 08/31/2028
- Quantity
- 4,643 20mL-vials
- Distribution
- Nationwide in the USA
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-10
Source: openFDA enforcement record D-0827-2026 · search recall number D-0827-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.