[U.S. Food and Drug Administration]

Communication Dynamics: A Resource in Assuring Drug Quality


Table 1. FDA Recall Classifications

Class I:
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II:
A situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III:
A situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences.

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