Cetuximab recalls

The FDA has published 2 recalls involving Cetuximab since 2018. The latest was reported on 21 Aug 2019. Most were for labeling errors. Infusion Options has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Aug 2019

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why cetuximab is recalled

Labeling Errors150%
Sterility150%

Companies

Infusion Options150%
Eli Lilly150%

By year

2019150%
2018150%

All cetuximab recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Cetuximab 335 MG / Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY
21 Nov 2018Drug	CLASS III	Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial recalledErbitux	Eli Lilly	Labeling Errors	11 states

Should you stop taking Cetuximab?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.