What FDA recall classes mean: Class I, II and III
Not medical advice. This guide summarizes public information from U.S. government health agencies for general education. It is not a substitute for advice from a doctor, pharmacist or other qualified health professional. If you have symptoms or questions about your health, contact a health professional. In an emergency, call 911.
When you read an FDA recall notice, you will usually see a label such as "Class I" or "Class II." That one phrase tells you a lot about how worried you should be. This guide explains each class in plain English, using the FDA's own definitions, and covers a few related terms you may run into.
Who starts a recall?
According to the FDA, a recall is an action taken by a company to remove a product from the market. Recalls can happen in three ways: the company starts one on its own, the FDA requests one, or the FDA orders one under its legal authority. Most of the recalls you see in FDA enforcement reports are listed as "voluntary," meaning the company carried them out.
Once a recall is under way, the FDA reviews the health hazard and assigns a classification. The class reflects the level of risk to people, not the size of the recall. A small recall can be Class I, and a nationwide recall can be Class III.
Class I: the most serious
The FDA defines a Class I recall as "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."
In everyday terms: if you have this product, take it seriously. Examples that appear in recent FDA enforcement reports include:
- Foods that may contain Listeria monocytogenes, Salmonella or Shiga toxin-producing E. coli.
- Foods that contain a major allergen, such as peanuts or milk, that is not on the label.
- Products marketed as dietary supplements that contain hidden drug ingredients.
- Injectable drugs with sterility problems, or a mix-up in which a container holds a different drug or strength than the label says.
For medicines, the FDA's consumer guide on drug recalls says Class I recalls are urgent, generally involve removing the drug from the market, and are generally carried out at the consumer level. It adds that Class I notifications generally include instructions for patients, and that the FDA recommends following the recalling company's instructions.
You can browse current examples on our Class I recalls page.
Class II: possible temporary health problems
The FDA defines Class II as "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 II covers a wide range of problems. In food, this can include certain contamination or labeling issues judged less likely to cause serious harm. In drugs, Class II recalls often involve manufacturing or quality problems, such as a tablet that does not dissolve properly or a product that failed stability testing.
For drugs, the FDA says Class II recalls are generally conducted at the retail level, and patients can generally continue using the medicine unless the recalling company or the FDA directs otherwise. That is important: stopping a prescribed medicine on your own can sometimes be riskier than finishing it. See our guide on what to do with recalled medication.
Class III: unlikely to cause harm
The FDA defines Class III as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences."
These products still break FDA rules, which is why they are being recalled, but the problem is not expected to hurt anyone. The FDA's drug recall guide gives examples such as minor labeling errors, defective packaging or incorrect expiration dates. For drugs, Class III recalls are generally conducted at the wholesale level, and consumers can generally keep using the medicine unless told otherwise.
Quick comparison
- Class I: reasonable probability of serious health consequences or death. Act right away.
- Class II: may cause temporary or medically reversible problems; serious harm is unlikely. Check your product and follow the instructions.
- Class III: not likely to cause health problems. Usually a labeling or quality issue.
Related terms you may see
The FDA also uses a few labels that are not recall classes:
- Market withdrawal. The FDA describes this as a product with a minor violation that would not be subject to FDA legal action. The company removes the product or fixes the problem. For example, a product removed because of tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
- Medical device safety alert. Issued when a medical device may present an unreasonable risk of substantial harm. Some of these are also treated as recalls.
- Terminated recall. On its recall lists, the FDA explains that a terminated recall is one where the agency has determined that all reasonable efforts have been made to remove or correct the product. Recalls not marked as terminated are either ongoing or completed.
- Not yet classified. Occasionally a recall appears in FDA data before the class is assigned.
What the class means for you
The class is a quick guide to urgency, but it is not the whole story. Two things matter just as much:
- Whether your product actually matches. Recalls cover specific lots, sizes and dates. Our guide on how to check if your food has been recalled explains how to compare codes.
- Who is using the product. A Listeria recall matters most for people who are pregnant, older adults and people with weakened immune systems. An allergen recall matters for people with that allergy. See Listeria, Salmonella and E. coli recalls explained and undeclared allergen recalls.
Whatever the class, if you have symptoms or concerns, contact a doctor or pharmacist. Every recall page on Recall Radar shows its class, and you can filter the home page by class.
Frequently asked questions
What is the most serious type of FDA recall?
Class I. The FDA defines it as a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.
Is a Class II recall dangerous?
It can be. The FDA defines Class II as a situation in which the product may cause temporary or medically reversible health problems, or where the probability of serious health problems is remote. It is less serious than Class I, but you should still check whether you have the product and follow the company's instructions.
Does Class III mean the product is safe?
Class III means use of or exposure to the product is not likely to cause adverse health consequences. These recalls often involve problems such as labeling errors, defective packaging or incorrect expiration dates. The product still breaks FDA rules, so it is being removed or corrected.
Who decides the recall class?
The FDA assigns the class based on the degree of health risk. A recall itself can be started by the company on its own, at FDA's request, or by FDA order under its legal authority.
Why does a recall say 'Not Yet Classified'?
Some recalls appear in FDA data before the agency has finished assigning a class. Treat them with care and check back, or follow the company's instructions in the meantime.