Class I, II and III recalls: what the classes mean
The class tells you how serious the health risk is, from Class I (could cause serious harm or death) to Class III (unlikely to make anyone sick). The FDA and USDA set it after the recall is announced.
Short answer: Class I is the most serious recall: a reasonable probability of serious health consequences or death. Class II may cause temporary or medically reversible health problems. Class III is unlikely to cause any health problem. The class describes the risk, not what you should do: for any class, follow the official notice.
The three classes
| Class | FDA definition (food, drugs, devices, cosmetics) | USDA FSIS (meat, poultry, eggs) |
|---|---|---|
| Class I | “A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” | High or medium risk: “a reasonable probability that the use of the product will cause serious, adverse health consequences or death.” |
| Class II | “May cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” | Low risk: “a remote probability of adverse health consequences from the use of the product.” |
| Class III | “Not likely to cause adverse health consequences.” | Marginal risk: “the use of the product will not cause adverse health consequences or the risk is negligible.” |
Quoted from 21 CFR 7.3(m) and the USDA FSIS recall classifications.
Who sets the class, and when
- The agency, after the announcement. A company’s press release usually comes first. The FDA lists recalls in its weekly Enforcement Report as Class I, II, III or “not yet classified” and adds the class once its hazard assessment is done. That is why most FDA recall announcements, including the 900 on this site, do not state a class.
- USDA FSIS announces meat, poultry and egg recalls with the class already set. Of the 52 FSIS notices on this site, 33 are Class I, 1 Class II, 0 Class III and 18 are public health alerts.
- The CPSC (household products, toys, appliances) does not print a class on its recall notices. None of the 595 CPSC recalls on this site has one; judge the risk from the hazard and injuries described in the notice.
Recall, market withdrawal, public health alert
| Term | What it means |
|---|---|
| Recall | A company removes or corrects a product the agency considers in violation of the law. It gets a class (I, II or III). |
| Market withdrawal | Removal or correction of a product with a minor violation that would not be subject to FDA legal action, or with no violation, such as normal stock rotation (21 CFR 7.3(j)). |
| Public health alert | A USDA FSIS warning without a recall. In alerts on this site FSIS explained that “a recall was not requested because the affected product is no longer available for purchase”: it may still be at home in a freezer or fridge. |
What the class means for you
- Check your package first, whatever the class: product, size, UPC and lot or date code (where to find the lot number).
- Follow the notice. It says whether to throw the product away, return it for a refund or stop using it. The class does not change that.
- A missing class is not a low class. “Not yet classified” only means the agency has not finished its evaluation.
Recent examples
USDA Class I recalls
- Ajinomoto Foods North America, Inc. Expands Recall for Chicken and Pork Fried Rice, Ramen, and Shu Mai Products Due to Possible Foreign Matter Contamination
- Rosina Food Products, Inc. Recalls Ready-To-Eat Frozen Meatball Products Due To Possible Foreign Matter Contamination
- Ajinomoto Foods North America, Inc. Recalls Chicken Fried Rice Products Due to Possible Foreign Matter Contamination
- Imperio Distribution LLC Recalls Beef Jerky Products Produced Without the Benefit of Inspection
USDA public health alerts
- FSIS Issues Public Health Alert for Steak Burrito Product Due to Misbranding and Undeclared Allergen
- FSIS Issues Public Health Alert for Boneless Chicken Breast Product Due to Misbranding and Undeclared Allergens
- FSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
- FSIS Retracts Public Health Alert for Frozen, Ready-to-Eat Chicken Nuggets Due to Updated Laboratory Result
See recalls by store: Costco, Walmart, Trader Joe’s, Aldi, Kroger, Target.
Common questions
What is a Class I recall?
The most serious kind. The FDA defines it as a situation with a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. USDA FSIS uses nearly the same wording for meat, poultry and egg products.
Is a Class II recall dangerous?
It is a lower risk, not no risk. The FDA defines Class II as a product that may cause temporary or medically reversible health problems, or where the probability of serious harm is remote. Follow the recall notice either way.
What is the difference between a recall and a market withdrawal?
The FDA defines a market withdrawal as a company’s removal or correction of a product with a minor violation that would not be subject to FDA legal action, or with no violation at all, for example normal stock rotation.
Why does a new recall have no class?
The class is set by the agency after a health hazard evaluation, not by the company’s announcement. The FDA lists new recalls as “not yet classified” in its weekly Enforcement Report and updates the entry once the class is assigned.
What is a USDA public health alert?
A warning FSIS issues instead of a recall request. In recent alerts FSIS wrote that a recall was not requested because the product was no longer available for purchase, while some may still be in people’s freezers or refrigerators.
Sources: 21 CFR 7.3 (FDA recall definitions) · FDA Enforcement Reports · USDA FSIS recall classifications · FSIS recalls & public health alerts. Checked Nov 8, 2026.