Quick answers
- What is Cetuximab used for?
- The FDA-approved label (Erbitux, ImClone LLC, April 16, 2026) says: “ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1, 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cetuximab have a boxed warning?
- Yes. The FDA label for Erbitux has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cetuximab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cetuximab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 8, 2018 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Cetuximab?
- 1 company lists prescription products of Cetuximab in the FDA NDC Directory, including ImClone LLC.
What Cetuximab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1, 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. …
— FDA label: Erbitux, ImClone LLC, effective April 16, 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.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Erbitux |
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.
- ImClone LLC2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125084 ERBITUX | Imclone | February 12, 2004 | 26, latest September 24, 2021 2021: Efficacy · 2021: Efficacy · 2021: 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.
-
November 8, 2018 · Class III · Terminated · D-0248-2019
Labeling: Missing label; potential for missing primary container label on the vial.
ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23 — Eli Lilly & Co
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
| RxCUI (RxNorm) | 1657658, 1657660, 1657663, 1657664 |
|---|---|
| SPL set ID of the quoted label | 8bc6397e-4bd8-4d37-a007-a327e4da34d9 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125084 |
| Active ingredients (FDA) | CETUXIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Erbitux, ImClone LLC, effective April 16, 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 →