Why it was recalled
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 16UI07, Exp 08/31/2028
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0827-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 10, 2026
- FDA report date
- Sep 2, 2026
- Quantity
- 4,643 20mL-vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0827-2026, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99603
- Address
- 3 Corporate Dr
- Code information
- Lot: 16UI07, Exp 08/31/2028
- Postal code
- 60047-8930
- Report date
- Sep 2, 2026
- Product type
- Drugs
- Recall number
- D-0827-2026
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 4,643 20mL-vials
- Reason for recall
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 10, 2026
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 1, 2026