How FDA Recalls Work

What is an FDA Recall?

An FDA recall is an action taken to remove a product from the market when there is reason to believe it may be adulterated, misbranded, or otherwise in violation of laws administered by the FDA. Recalls are one of the most important tools the FDA has to protect public health and ensure the safety of the food supply.

Most food recalls are initiated voluntarily by manufacturers or distributors when they discover a potential problem. In rare cases, the FDA can request or mandate a recall when a company is unwilling to act on its own.

Recall Classifications

The FDA assigns one of three classification levels to each recall based on the severity of the health risk. Understanding these classifications can help you assess how urgently you need to act.

Class I Most Serious

A Class I recall involves a situation in which there is a reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences or death. These recalls require immediate consumer attention.

Example: Listeria monocytogenes contamination in ready-to-eat deli meats, which can cause life-threatening infections in pregnant women, the elderly, and immunocompromised individuals.

Class II Moderate Risk

A Class II recall involves a situation in which the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Example: An undeclared allergen (such as milk, soy, or tree nuts) in a food product that could cause allergic reactions in sensitive individuals.

Class III Low Risk

A Class III recall involves a situation in which the use of, or exposure to, the product is not likely to cause adverse health consequences. While these recalls still represent a regulatory violation, the immediate health risk is minimal.

Example: A minor labeling error where the net weight is slightly inaccurate, or a product with a cosmetic packaging defect that does not affect food safety.

Voluntary vs. Mandated Recalls

Voluntary Recalls

The vast majority of food recalls are voluntary. The manufacturer or distributor discovers a problem and takes the initiative to remove the product from the market. The FDA monitors these recalls to ensure they are carried out effectively.

Mandated Recalls

In rare cases where a company refuses to recall a product voluntarily, the FDA has the authority to order a mandatory recall. This power was granted under the FDA Food Safety Modernization Act (FSMA) and is used when there is a reasonable probability that the food is adulterated or misbranded and could cause serious health consequences.

What to Do If You Have a Recalled Product

1

Stop using the product immediately

Do not consume, cook with, or serve the recalled product. If the product is perishable, seal it in a bag to prevent cross-contamination.

2

Check the recall details

Review the recall notice for specific product details such as lot numbers, UPC codes, expiration dates, and distribution areas to confirm your product is affected.

3

Return or dispose of the product

Follow the recall instructions. Most recalls offer a full refund if you return the product to the retailer. If instructed to dispose of it, do so safely.

4

Seek medical attention if needed

If you or anyone in your household has consumed the recalled product and is experiencing symptoms, contact your healthcare provider immediately.

How to Report Problems to the FDA

If you believe you have experienced a food safety issue or have information about a potentially unsafe product, you can report it directly to the FDA.

MedWatch Safety Reporting

Submit a voluntary safety report online at FDA MedWatch .

Consumer Complaint Coordinator

Contact your local FDA Consumer Complaint Coordinator by phone. Find your regional contact at FDA Consumer Complaint Coordinators .

FDA Emergency Line

For emergencies involving food products, call the FDA's 24-hour emergency number at 1-866-300-4374.