Which class of FDA recall is issued when there is a high probability that use will cause serious adverse health effects?

• A. Class II recall
• B. Class III recall
• C. Class I recall
• D. Class IV recall

Answer: (C)

When evaluating FDA recalls, the level used depends on how likely it is that use will cause harm and how serious that harm would be. If there is a reasonable probability that use will cause serious adverse health effects or death, the product is placed in the most severe recall category. This ensures immediate action to protect public health, such as rapid public warnings and widespread removal or corrective actions.

That’s why the correct choice is the most severe category. The other categories describe progressively less serious or less likely outcomes: a recall for temporary or reversible health effects, or for issues unlikely to cause health problems. The fourth label is not part of the standard FDA recall framework, so it doesn’t fit the situation described.