What do FDA recall Class I, Class II and Class III mean?

Information as of 16 October 2026. Everything below comes from the FDA's recall regulations in 21 CFR Part 7 and its background page on recalls, linked below. If anything here is wrong, tell us at contact@oqro.io and we will correct it.

How does the FDA define the three classes?

The definitions are in 21 CFR 7.3. A recall classification is the numerical designation, I, II or III, assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

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

The same section defines a recall as a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. A market withdrawal, by contrast, is a firm's removal or correction of a product involving a minor violation that would not be subject to legal action, or no violation at all, and is not a recall. A stock recovery is the removal of product that has not been marketed or has not left the firm's direct control.

Who starts a recall, and who classifies it?

The FDA's background page explains that most recalls are voluntary actions by the firm, either on its own initiative or at the agency's request. The agency classifies the recall, evaluates the firm's strategy, and publishes the recall in its weekly Enforcement Report once it has been classified. A firm-initiated recall may appear in the report some time after the firm began it, which is why a record carries both the date the firm started the recall and the date the FDA published it. The agency can also request a recall when a firm has not acted, and for some products it has the power to order one.

The regulation describes the elements of a recall strategy: the depth of recall (wholesale, retail or consumer level), whether a public warning is needed, and the effectiveness checks the firm will use to confirm that consignees have been notified. The status of a recall in the report moves from Ongoing to Completed, or to Terminated once the agency determines that reasonable efforts have been made to remove or correct the product.

Where does OQRO show recalls?

The FDA records page lists recalls of drugs, devices and foods by listed companies alongside approvals and clearances, with the class, the product, the reason as the FDA wrote it and the link to the enforcement report entry. Each company page carries its own. The approval routes that bring a product to market are described in our article on NDA, ANDA, 510(k) and PMA. A recall is matched by the recalling firm's name, so a product recalled under a subsidiary that OQRO does not know is not shown.

What this does not tell you

The class describes the hazard the FDA assigned, not the number of units or patients involved, and not the cause: the reason field is the firm's statement of the problem. One product can appear in several entries when it has several lots or package sizes, each with its own recall number. A recall does not say whether the product is still sold, whether it was replaced, or what it cost the company. OQRO shows the record as published; it does not interpret it, and nothing here is investment advice.