Recall Classification
Class I / II / III
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
When a marketed product is removed or corrected because it violates the law or poses a risk, the action is classified by the severity of the health hazard: Class I where there is a reasonable probability that use will cause serious adverse health consequences or death; Class II where use may cause temporary or medically reversible harm, or where serious harm is remote; and Class III where use is unlikely to cause adverse health consequences. The class drives the urgency, depth (how far down the distribution chain), and public communication of the recall. Most recalls are voluntary actions by the firm, with the authority assigning the classification.
Classification is a health-hazard judgment made using a defined evaluation of the risk, not a measure of how egregious the underlying GMP failure was. A minor labeling error and a life-threatening contamination can both be "recalls," but they sit in very different classes.
The class determines effectiveness checks and the extent of the recall — a Class I recall typically reaches the consumer/patient level with aggressive notification, whereas a Class III may stop at a wholesale level.
- —Class I: reasonable probability of serious harm or death
- —Class II: temporary/reversible harm or remote serious harm
- —Class III: unlikely to cause adverse health consequences
- —Class sets depth, urgency, effectiveness checks, and public notice
US recall classifications, 21 CFR Part 7.
Frequently asked questions
What does Recall Classification stand for?
Recall Classification stands for Class I / II / III.
What is Recall Classification?
When a marketed product is removed or corrected because it violates the law or poses a risk, the action is classified by the severity of the health hazard: Class I where there is a reasonable probability that use will cause serious adverse health consequences or death; Class II where use may cause temporary or medically reversible harm, or where serious harm is remote; and Class III where use is unlikely to cause adverse health consequences. The class drives the urgency, depth (how far down the distribution chain), and public communication of the recall. Most recalls are voluntary actions by the firm, with the authority assigning the classification.
Which regulations cover Recall Classification?
US recall classifications, 21 CFR Part 7.