RecallLensGuides · Updated 2026-11-10
FDA recall classes: Class I, Class II and Class III
FDA sorts recalls of food, drugs, medical devices and other products it regulates into three classes by how much harm the product could do. The class tells you how serious FDA judged the problem, not how many units are involved.
The three classes
| Class | Meaning (21 CFR 7.3) | Paragraph |
|---|---|---|
| Class I | A reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. | 7.3(m)(1) |
| Class II | Use or exposure may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. | 7.3(m)(2) |
| Class III | Use or exposure is not likely to cause adverse health consequences. | 7.3(m)(3) |
Recall vs market withdrawal
A market withdrawal (7.3(j)) is a firm removing or correcting a product that has a minor violation FDA would not take legal action on, or no violation at all; for example, a product pulled for a quality issue that does not break the rules. Under 7.3(g), a recall does not include a market withdrawal or a stock recovery.
Who starts a recall
FDA's recall background page says a recall can be carried out on the firm's own initiative, at FDA's request, or by FDA order under statutory authority.
Searching FDA recalls by class
FDA's enforcement reports are published as open data through openFDA, with fields for the product type (food, drug, device), the classification and the recall status. You can filter them by class and date. In Claude, the free RecallLens connector's FDA tool takes a classification ("Class I", "Class II" or "Class III"), a product type, a status and a date range, for example: "Class I food recalls since September".
Look it up from a chat
RecallLens is a free connector for Claude that looks up NHTSA vehicle recalls (by make, model and year, by VIN, or by campaign number), FDA food, drug and device recalls and CPSC consumer product recalls, and links each answer to the official record. No sign-in or API key. Add it to Claude.
This guide summarizes public federal rules in plain English. It is not legal advice. Rules have exceptions and can change; read the linked text, and for a specific vehicle or product ask the manufacturer, dealer, pharmacist or the agency. RecallLens is published by Starry Night and is not affiliated with NHTSA, FDA, CPSC or any government agency.
Questions
What is a Class I recall?
Under 21 CFR 7.3(m)(1), a situation where there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. It is the most serious class.
What is the difference between Class II and Class III?
Class II (21 CFR 7.3(m)(2)) covers products that may cause temporary or medically reversible health effects, or where serious harm is remote. Class III (7.3(m)(3)) covers products not likely to cause adverse health consequences.
Is a market withdrawal a recall?
No. 21 CFR 7.3(j) defines a market withdrawal as removing or correcting a product with a minor violation FDA would not act on, or no violation, and 7.3(g) says a recall does not include a market withdrawal.