Fresenius Kabi USA, LLC recalls Tyenne
- Recalling company
- Fresenius Kabi USA, LLC
- 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
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Aug 10, 2026
- Reported
- Sep 2, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 4,643 20mL-vials
- Lot / codes
- Lot: 16UI07, Exp 08/31/2028
- Company location
- Lake Zurich, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0827-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0827-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.