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
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Agency
- FDA Drug
- Recall date
- Aug 10, 2026
- Status
- Ongoing
- Company
- Fresenius Kabi USA, LLC
1. What product was recalled?
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
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.
Quantity: 4,643 20mL-vials
Code or lot text: Lot: 16UI07, Exp 08/31/2028
- LOT
- Exp 08/31/2028
- LOT
- Lot: 16UI07
- NDC
- 65219-590
- NDC
- 65219-590-04
- NDC
- 65219-592
- NDC
- 65219-592-10
- NDC
- 65219-594
- NDC
- 65219-594-20
- RECALL-NUMBER
- D-0827-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.