Drug recalls are classified into three main categories based on the severity of the risk associated with the product:
Class I: Involves a situation where 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: Involves a situation where use or exposure may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III: Involves a situation where use or exposure is not likely to cause adverse health consequences.
