Understanding FDA drug recalls and what they mean

A drug recall happens when a product is removed or corrected because it violates FDA regulations — for example, contamination, mislabeling, or a manufacturing defect.

Why we use recalls

Unlike raw adverse-event report counts (which are skewed by how many people take a drug), a recall is an objective quality failure attributable to the manufacturer. That makes it a fair, comparable safety signal.

Recall classes

• Class I — reasonable probability of serious harm or death.
• Class II — temporary or reversible harm.
• Class III — unlikely to cause harm.

How it affects a score

In our composite, a manufacturer with more recalls receives a lower quality signal — which flows through to the products they make.