How Drug Recall Classifications Work

The FDA assigns a classification to every drug recall based on a health hazard evaluation. This evaluation considers the type of defect or contamination, the likelihood that patients will be harmed, the severity of potential health effects, and the population most at risk.

Class I recalls are the most serious. They are issued when there is a reasonable probability that use of the drug will cause serious health problems or death. Common triggers include contamination with dangerous impurities, sterility failures in injectable drugs, and significant potency problems.

Class II recalls cover situations where using the product may cause temporary or medically reversible adverse health effects, or where the probability of serious health consequences is remote.

Class III recalls involve products unlikely to cause any adverse health effects. These often arise from cGMP violations, minor labeling issues, or technical defects that don't affect the drug's safety or efficacy.

Drug Recall Classifications

FDA drug recalls are classified into three levels based on the severity of the health hazard.