Class IDrug
Tyenne recall
Summary
Fresenius Kabi USA, LLC is recalling Tyenne (tocilizumab-aazg) Injection (drug). According to the FDA report, the reason is: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
Fresenius Kabi is recalling Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after an internal investigation found glass particles in the product.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously.
Who should pay attention
Infusion centers, hospital pharmacies and patients who receive Tyenne, a tocilizumab biosimilar.
Distribution in the FDA report: Nationwide in the USA
How to check your product
Check the lot number and expiration date on the vial or carton.
Codes listed by the FDA: Lot: 16UI07, Exp 08/31/2028
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- 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.
- Lot / code info
- Lot: 16UI07, Exp 08/31/2028
- Quantity
- 4,643 20mL-vials
- Distribution
- Nationwide in the USA
- Recalling company
- Fresenius Kabi USA, LLC, Lake Zurich, IL United States
- Recall started
- August 10, 2026
- FDA report date
- September 2, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0827-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Fresenius Kabi USA, LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.