Home / Recalls / Fresenius Kabi USA, LLC / D-0827-2026

D-0827-2026 Class I Ongoing

Recalled by Fresenius Kabi USA, LLC — Lake Zurich, IL

FDA drug recall D-0827-2026 was initiated by Fresenius Kabi USA, LLC on August 10, 2026 and is designated Class I. Reason for recall: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. The recall status is ongoing. Affected quantity: 4,643 20mL-vials.

Recall Details

Product Type: Drugs
Report Date: September 2, 2026
Initiation Date: August 10, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,643 20mL-vials

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.

Reason for Recall

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 16UI07, Exp 08/31/2028

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