Recall Classification

Key facts

Defined in

21 CFR 7.3(m)

Assigned by

FDA, after a health hazard evaluation (21 CFR 7.41)

Class I

Reasonable probability of serious adverse health consequences or death

Class II

Temporary or medically reversible harm, or remote chance of serious harm

Class III

Not likely to cause adverse health consequences

What is recall classification?

When a company recalls a product regulated by the Food and Drug Administration (FDA), FDA evaluates the health hazard and assigns a class. The class describes how dangerous the recalled product is, not how many units are involved or who started the recall.

The same three classes apply to drugs, biologics, medical devices, foods and other FDA-regulated products. Class I is the most serious and Class III the least.

Classification can come days or weeks after a firm begins its recall, and a recall appears in the weekly Enforcement Report only after FDA has classified it.

The three recall classes

FDA regulations define the classes as follows:

In deciding the class, FDA considers whether injuries have already occurred, which populations are exposed, how serious the potential harm is, how likely it is to occur, and its immediate and long-term consequences.

• Class I: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death, as with a sterile injectable found to be contaminated.
• Class II: use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. Many drug quality failures, such as out-of-specification dissolution, fall here.
• Class III: use of or exposure to the product is not likely to cause adverse health consequences, as with some minor labeling or packaging defects.

Why recall classification matters

The class drives both urgency and analysis:

• Operational priority: Class I recalls usually demand faster action and deeper retrieval, often to the patient level, and are more likely to get a press release.
• Supplier quality scoring: counting Class I and II recalls by manufacturer and facility over time gives a rough quality track record for sourcing and due diligence.
• Trend analysis: classes and classification dates in Enforcement Report data allow comparisons across product types, firms and years.

Common misconceptions about recall classes

Recall classes are not medical device classes. Device Classes I, II and III describe risk for premarket review, so a Class II device can be the subject of a Class I recall.

A higher-numbered class is less severe, not more. And one recall event often covers many products, lots or NDCs, so counting product records overstates the number of separate recall decisions.