Recall archive / FDA company announcement

Fresenius Kabi: Tyenne Injection 400 mg/20 mL vial — FDA announcement Aug 11, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Tyenne Injection 400 mg/20 mL vial
Reason: Due to Presence of Glass Particles
Classification: Not supplied
Recalling firm: Fresenius Kabi
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 1b670650d67911d9

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	August 10, 2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles.; Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.; Product Name/Size \| NDC Number \| Product Code \| Lot Number \| Expiration Date \| First Ship Date \| Last Ship Date; Tyenne® (tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial \| 65219-594-20 \| 590120 \| 16UI07 \| 08/2028 \| 03/03/2026 \| 03/25/2026

Label field

Details supplied by the agency

Lot, code or applicability

August 10, 2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles.; Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.; Product Name/Size | NDC Number | Product Code | Lot Number | Expiration Date | First Ship Date | Last Ship Date; Tyenne® (tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial | 65219-594-20 | 590120 | 16UI07 | 08/2028 | 03/03/2026 | 03/25/2026

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product Name/Size	NDC Number	Product Code	Lot Number	Expiration Date	First Ship Date	Last Ship Date
Tyenne® (tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial	65219-594-20	590120	16UI07	08/2028	03/03/2026	03/25/2026

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Aug 11, 2026
Company announcement date: Aug 10, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.