Quick answers
- What is Ustekinumab-srlf used for?
- The FDA-approved label (Imuldosa, Accord BioPharma Inc., June 17, 2026) says: “IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. active psoriatic arthritis in adult and pediatric patients 6 years of age and older. moderately to severely active Crohn’s disease in adult patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ustekinumab-srlf have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ustekinumab-srlf?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ustekinumab-srlf been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 10, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ustekinumab-srlf?
- 1 company lists prescription products of Ustekinumab-srlf in the FDA NDC Directory, including Accord BioPharma Inc..
What Ustekinumab-srlf is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. active psoriatic arthritis in adult and pediatric patients 6 years of age and older. moderately to severely active Crohn’s disease in adult patients. …
— FDA label: Imuldosa, Accord BioPharma Inc., effective June 17, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Imuldosa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Accord BioPharma Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761364 IMULDOSA | Accord Biopharma Inc. | October 10, 2024 | 3, latest June 5, 2026 2026: Bioequivalence · 2025: Labeling · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 10, 2026 · Class II · Ongoing · D-0653-2026
Lack of assurance of Sterility:
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 Ind — ACCORD BIOPHARMA INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Imuldosa, Accord BioPharma Inc., effective June 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →