FDA recall D-0653-2026

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 for recall

Lack of assurance of Sterility:

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-06-10

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2026