Eli Lilly ERBITUX Injection Recall: Missing Label Risk
Eli Lilly recalls ERBITUX cetuximab injection vials due to missing primary container labels, which could lead to incorrect use. Affected vials have specific NDC and lot numbers.
Use caution until it’s fixed
Labeling: Missing label; potential for missing primary container label on the vial.
Contact the company
What happened, in plain English
Eli Lilly is recalling ERBITUX cetuximab injection vials because they may lack the primary label. This could cause incorrect use if the label is missing, which is serious for patients needing precise medication administration. Read more at govinfonow.com/recall/39436-eli-lilly-erbitux-injection-recall-missing-label-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39436-eli-lilly-erbitux-injection-recall-missing-label-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0248-2019
Cite this page
“Eli Lilly ERBITUX Injection Recall: Missing Label Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39436-eli-lilly-erbitux-injection-recall-missing-label-risk. Based on FDA recall #D-0248-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0248-2019%22&limit=1).
Why it’s dangerous
Missing labels on the vial could lead to incorrect medication use. Since this is a prescription drug, improper labeling might cause dosing errors that could harm patients.
Who’s affected
Patients prescribed ERBITUX cetuximab injection by a doctor are affected. Those using the product without proper labeling are at higher risk of incorrect dosing.
How to tell if you have this one
Check for the NDC number 66733-958-23 and lot number C1700167 on the vial. The product was manufactured by ImClone LLC in Branchburg, NJ and expires September 2020.
- Brand
Eli Lilly- Category
Drug
What to do — step by step
Check Label
Look for the primary container label on the vial. If missing, stop using the product.
Where it went and when
Where it was distributed
Distributed in 10 states and Puerto Rico.
FDA distribution: “AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Kansas, Louisiana, Mississippi, Ohio, Oregon, Puerto Rico, Tennessee, Texas.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0248-2019 (November 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0248-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.