FDA recall classes I / II / III

Claim

FDA classifies recalls by relative health hazard: Class I — reasonable probability that use/exposure will cause serious adverse health consequences or death; Class II — use/exposure may cause temporary or medically reversible adverse health consequences, or probability of serious consequences is remote; Class III — use/exposure is not likely to cause adverse health consequences. Class is assigned by FDA; market withdrawal is a different action for minor issues not rising to FDA legal action.

Plain

I = serious harm/death likely. II = temporary/reversible or serious harm remote. III = unlikely to cause harm. Know the three classes; don’t confuse with market withdrawal.

Citations

1. FDA — Recalls Background and Definitions (FDA recall Class I / II / III definitions) — source
   

   Class I recall: 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 recall: a situation in which 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 recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

   retrieved 2026-09-08