Recall: D-0653-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-10Initiated

OngoingStatus

ACCORD BIOPHARMA INCFirm

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

Lack of assurance of Sterility:

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.