FDA Drug · 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.

Class II · Ongoing

Lack of assurance of Sterility:

Affected lots / codes — check yours against thisLot # 004L24A, Exp Date: 02/19/2027.

Recalling firm: ACCORD BIOPHARMA INC, Raleigh, NC
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 326 vials
Distribution: US Nationwide.
Recall initiated: June 10, 2026
Classified: June 29, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0653-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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