IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL)

ACCORD BIOPHARMA INC has recalled IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 8, 2026 and was initiated on June 10, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), with approximately 326 vials affected. The company behind the recall is ACCORD BIOPHARMA INC, based in Raleigh, NC. The FDA describes the product as: “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, Blo…”

Why was IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL) recalled?

According to the FDA, the stated reason for the recall is: “Lack of assurance of Sterility:.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), compare it against the product description and identifying codes (Lot # 004L24A, Exp Date: 02/19/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact ACCORD BIOPHARMA INC or your local health authority.

About this recall

This recall was distributed in NC. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.