Tyenne Injection, Solution, Concentrate
FDA Recall NDC 65219-590
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tyenne (NDC 65219-590). A significant event, classified as Class I, was initiated on Aug 10, 2026 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Aug 10, 2026
Sep 02, 2026
4,643 20mL-vials
Recall Profile & Regulatory Data
Event ID
99603
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# Lot: 16UI07, Exp 08/31/2028
Affected Packages Involved in this Recall
65219-590-04Product
65219-592-10Product
65219-594-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
