Quick answers
- What is Infliximab used for?
- The FDA-approved label (Remicade, Janssen Biotech, Inc., June 3, 2025) says: “REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Infliximab have a boxed warning?
- Yes. The FDA label for Remicade has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Infliximab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Infliximab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 17, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Infliximab?
- 4 companies list prescription products of Infliximab in the FDA NDC Directory, including Janssen Biotech, Inc., Organon LLC and Pfizer Laboratories Div Pfizer Inc.
What Infliximab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. …
— FDA label: Remicade, Janssen Biotech, Inc., effective June 3, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
This label has a boxed warning. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.2 products
- Organon LLC1 product
- Pfizer Laboratories Div Pfizer Inc1 product
- Amgen, Inc1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103772 REMICADE | Centocor Inc | August 24, 1998 | 55, latest February 28, 2025 2025: Labeling · 2021: Labeling · 2020: Labeling |
| BLA125544 INFLECTRA | Celltrion Inc | April 5, 2016 | 4, latest September 3, 2025 2025: BIOSIMILAR · 2021: Labeling · 2019: Efficacy |
| BLA761054 RENFLEXIS | Samsung Bioepis Co Ltd | April 21, 2017 | 5, latest October 28, 2025 2025: Labeling · 2023: Labeling · 2022: Manufacturing (CMC) |
| BLA761086 AVSOLA | Amgen Inc | December 6, 2019 | 2, latest August 25, 2025 2025: BIOSIMILAR · 2021: 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.
-
January 17, 2025 · Class II · Ongoing · D-0213-2025
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — McKesson
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) — Remicade, Janssen Biotech, Inc., effective June 3, 2025; 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 →