# FDA recall classifications: Class I, II, and III explained

> What the different FDA recall classes mean and how they affect patient risk.

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**Last updated:** 2026-06-11

The FDA classifies recalls based on the severity of health risk. Class I recalls are the most serious, involving a reasonable probability that the product will cause serious adverse health consequences or death.

Class II recalls involve products that may cause temporary or medically reversible health consequences, where the probability of serious harm is remote. Class III recalls involve products unlikely to cause adverse health consequences.

When a recall is announced, check the classification to understand the risk level. Class I and II recalls may be relevant for legal cases if you were harmed. Preserve the product and documentation if affected.

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*Educational guide from DrugsMonitor.com. Not legal advice.*