Imuldosa Injection
FDA Recall NDC 69448-019

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 Imuldosa (NDC 69448-019). A significant event, classified as Class II, was initiated on Jun 10, 2026 by Accord Biopharma Inc.. The reported reason for this action was: "Lack of assurance of Sterility:"

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

D-0653-2026ONGOING

June 2026 Class II Recall: Lack of assurance of Sterility

Recall Number
D-0653-2026
Class II Ongoing
Reason for Recall
Lack of assurance of Sterility:
Initiated
Jun 10, 2026
Reported
Jul 08, 2026
Quantity
326 vials

Recall Profile & Regulatory Data

Event ID
99216
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD BIOPHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Batch or Lot Expiration Information
Lot# 004L24A, Exp Date: 02/19/2027.
Affected Packages Involved in this Recall
69448-018-63Product
69448-017-63Product
69448-019-26Product

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.