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Tyenne (tocilizumab-aazg) Injection, 400 mg 20 mL (20 mg mL), 20 mL vial, Rx Only

Official notice

2 Sept 2026

Last checked

22 Sept 2026

CriticalFDA

An official FDA notice concerns Fresenius Kabi. The notice reports a health risk requiring medical assessment. Do not use the product and follow the official notice. Published 2026-09-02. Lots: 16UI07, Exp. Recall numbers: D-0827-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

4,643

Recall number

D-0827-2026

Official notice

2026-09-02

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

16UI07, Exp

Event Ids

99603

Recall Numbers

D-0827-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fresenius Kabi. Contact: Fresenius Kabi USA, LLC.

Source & status

Source

Tier

official

Category

HEALTH

Classification

Class I

App estimate

critical

Recall details

Recall number

D-0827-2026

Event id

99603

Units affected

4,643

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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