Quick answers
- Is there a shortage of Guselkumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Guselkumab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 9, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Guselkumab?
- 1 company lists prescription products of Guselkumab in the FDA NDC Directory, including Janssen Biotech, Inc..
What Guselkumab is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Tremfya |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| guselkumab 100 mg/mL injection | Brand: Tremfya | $14,620.07–$14,734.21 per mL 3 packages, lowest to highest |
| guselkumab 200 mg/2 mL injection | Brand: Tremfya | $7,326.10 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Janssen Biotech, 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 |
|---|---|---|---|
| BLA761061 TREMFYA | Janssen Biotech | July 13, 2017 | 14, latest May 28, 2026 2026: Efficacy · 2025: Efficacy · 2025: Efficacy |
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.
-
March 9, 2021 · Class III · Terminated · D-0314-2021
Temperature Abuse
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01. — Cardinal Health 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
| FDA labels (SPL) | 0 |
|---|---|
| FDA applications | BLA761061 |
| Active ingredients (FDA) | GUSELKUMAB |
Sources
- 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 →