Recall: D-0827-2026

Class I - Dangerous

Class IClassification

2026-08-10Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

Product

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.