⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ACCORD BIOPHARMA INC: IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco c

DrugsSource: FDA (drug) · Date: 2026-07-08

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
ACCORD BIOPHARMA INC
Product
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.
Reason / hazard
Lack of assurance of Sterility:
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-06-10
Code info
Lot # 004L24A, Exp Date: 02/19/2027.
Product quantity
326 vials
Voluntary mandated
Voluntary: Firm initiated
City
Raleigh
State
NC
Country
United States
Event id
99216
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