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IMULDOSA, (ustekinumab-srlf) Injection recall

ACCORD BIOPHARMA INC recalled IMULDOSA, (ustekinumab-srlf) Injection on July 8, 2026 because of lack of assurance of Sterility:. It was sold nationwide.

Why it was recalled

Lack of assurance of Sterility:

What's recalled

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.

Quantity: 326 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
ACCORD BIOPHARMA INC, Raleigh, NC
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0653-2026
Source
U.S. Food and Drug Administration

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