---
title: "Fresenius Kabi: Tyenne Injection 400 mg/20 mL vial — FDA announcement Aug 11, 2026 | Is It on Recall"
description: "Due to Presence of Glass Particles"
url: https://isitonrecall.com/recall/fdapress-1b670650d67911d9-fresenius-kabi-tyenne-injection-400-mg-20-ml-vial/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-nationwide-recall-tyenner-tocilizumab-aazg-injection-400-mg20-ml-vials-due)

## 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 |

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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-nationwide-recall-tyenner-tocilizumab-aazg-injection-400-mg20-ml-vials-due).

## 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.

## What to do next

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-nationwide-recall-tyenner-tocilizumab-aazg-injection-400-mg20-ml-vials-due)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Fresenius Kabi records](https://isitonrecall.com/brand/fresenius-kabi/)