FDA recall classes explained
Class I recall
FDA definition: A situation in which there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Typical examples: Food contaminated with Listeria or E. coli O157:H7, an undeclared allergen like peanuts, a medicine with the wrong active ingredient.
What to do: Stop using the product right away. Check the lot code and follow the recall instructions.
14,718 of 47,469 FDA food and drug enforcement reports since 2012 (31%) were Class I.
Class II recall
FDA definition: A situation in which using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Typical examples: Tablets that fail dissolution tests, minor undeclared ingredients, some contamination unlikely to cause serious illness.
What to do: Check whether your product matches. For medicine, call your pharmacist before stopping it.
29,273 of 47,469 FDA food and drug enforcement reports since 2012 (62%) were Class II.
Class III recall
FDA definition: A situation in which using or being exposed to the product is not likely to cause adverse health consequences.
Typical examples: Labeling errors that don't affect safety, a container defect, a product that doesn't meet a quality specification.
What to do: Usually no health action is needed; the company may offer a refund or replacement.
3,478 of 47,469 FDA food and drug enforcement reports since 2012 (7%) were Class III.
Definitions follow the FDA's recall regulations (21 CFR 7.3) and the FDA's recalls background and definitions. Browse current Class I recalls.
Questions about recall classes
What is a Class 1 recall?
A Class I recall is the FDA's most serious recall category. It means there is a reasonable probability that using or being exposed to the product will cause serious health problems or death. If you have a product under a Class I recall, stop using it and check the lot code.
What is the difference between Class I, Class II, and Class III recalls?
The class reflects how dangerous the product is. Class I: a reasonable probability of serious health problems or death. Class II: may cause temporary or medically reversible health problems, or serious harm is remote. Class III: unlikely to cause health problems.
Is a Class II recall serious?
A Class II recall is less serious than Class I, but it can still cause temporary or reversible health problems. Check whether your product matches the recall, and for prescription medicine, talk to your pharmacist before stopping it.
Who decides the recall class?
The FDA assigns the class after a health hazard evaluation of the recalled product. That is why an FDA report can appear days or weeks after a company first announces a recall.
What is a market withdrawal?
A market withdrawal is when a company removes or corrects a product for a minor violation that would not lead to FDA legal action, such as a product removed for a reason unrelated to safety. It is not a recall class.