FDAFDA · Food and drugs·Recall number D-0653-2026
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.
Published July 8, 2026 · Recall initiated: June 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of Sterility:
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IMULDOSA
- Manufacturer
- ACCORD BIOPHARMA INC
- Distributor
- US Nationwide.
- UPC
- 0369448017637
- Lot
- Lot # 004L24A, Exp Date: 02/19/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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