The U.S. Food and Drug Administration describes a recall as an action taken by a company to correct or remove from the market an FDA-regulated product that violates U.S. laws and regulations. On a separate page, the agency says a recall is a firm’s step to take a product off the market. According to the FDA, a firm may start that step itself, the FDA may ask for it, or the FDA may require it under law, and a consumer page says a company may begin a recall on its own or after the FDA asks.
What the agency means by a recall
The FDA says recalls are important because they protect the public from products that may cause injury, illness, or even death. Most recalls involve removing violative FDA-regulated products from the market, according to the agency. A violation can sometimes be corrected without removing the products from distribution.
The FDA gives two examples of a correction that leaves a product in place. An MRI machine or other equipment may be too large to remove from a medical facility, and the issue could be corrected on site. Updated labeling may be affixed on a food product, prior to retail sale, to declare an ingredient previously not listed, such as wheat, milk, or peanuts.
A market withdrawal is different from a recall, according to the FDA. It occurs when a product has a minor violation that would not be subject to FDA legal action, and the firm removes the product from the market or corrects the violation. The agency’s example is a product removed from the market due to tampering, without evidence of manufacturing or distribution problems.
A medical device safety alert is issued in situations where a medical device may present an unreasonable risk of substantial harm, the FDA says. In some case, these situations also are considered recalls, according to the agency.
How the FDA classifies recalls
The FDA uses three classes for recalls. According to the agency, a Class I recall is a case in which it is reasonably likely that using a product that breaks the rules, or being exposed to it, will cause serious harm to health or death.
A Class II recall, the FDA says, is a case in which using a product that breaks the rules, or being exposed to it, may cause health harm that is temporary or can be reversed by medical care, or in which serious health harm is unlikely. The FDA says a Class III recall is a case in which using a product that breaks the rules, or being exposed to it, is unlikely to harm health.
Which products and problems are covered
The FDA’s list covers food for people, and that list includes dietary supplements, plus feed and food for animals, cosmetics, drugs for people and for animals, medical devices, products that emit radiation, vaccines, blood and products made from blood, human tissue that can be transplanted, and tobacco products.
Common reasons a product may be recalled, according to the FDA, include manufacturing defects and contamination with disease-causing microorganisms such as Salmonella and E. coli. The agency also lists foreign objects such as broken glass, metal fragments, or plastic; failure to list a major allergen; and failure to list a certain ingredient.
Other reasons the FDA lists are a risk of erroneous results when a product is used as directed, such as inaccurate diagnostic testing results; a non-sterile product intended to be sterile; adverse event reports; and software corrections or updates. The FDA says more than 83,000 FDA-regulated products were recalled between 2014 and 2024.
How notice reaches the public
The company initiating the product removal or correction generally issues a recall notification to its direct distributors or customers, the FDA says. That notice includes details that can be used to tell which products are recalled, including how the product is described, its brand or name, and the size and kind of package; the UPC, which the FDA identifies as the universal product code; and other product codes, such as lot codes, sell-by dates, or use-by dates. It may also include pictures of the packaging and labels, and distribution information, such as the states or stores in which the products were sold.
The notification may also explain the reason for the recall, according to the FDA. It may tell those direct customers what to do, and that can include telling their own customers if the product was passed on.
In the Enforcement Report, the FDA gives the public a written description of every new recall and, if classified, sorts that listing by the recall’s classification, according to the agency. The FDA offers a service that sends notices of every FDA recall each day or each week to people who sign up.
The agency says warnings to the public work well when a company or the FDA needs to tell people that a recalled product poses a serious danger to health. The FDA keeps a web page titled Recalls, Market Withdrawals, & Safety Alerts that gathers public warnings about some recalls of products the agency regulates. After a company announces a recall, a market withdrawal, or a safety alert, the FDA usually places that company announcement on the FDA website to serve the public. The FDA says it “does not endorse either the product or the company.”
A consolidated list of recalls from six federal agencies can be found at www.recalls.gov, according to the FDA. Product-specific information about recalls and enforcement actions can be found at the FDA center webpages responsible for that product. The agency names the Human Foods Program, the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, the Center for Veterinary Medicine, the Center for Tobacco Products, and the Center for Biologics Evaluation and Research. The FDA’s recalls background page also points to drug recall information for consumers, health care professionals, and industry.
What the FDA says about a product already in hand
The FDA says a person should go through the recall notice with care and check details such as the brand, the package size, and codes including expiration or best-by dates, to see whether that item is part of the recall. The agency says to follow any product-specific instructions and to contact the company for further information. Often, recalled products can be returned to the store where they were purchased, according to the FDA.
A medical device recall does not always mean that a person must stop using the product or return it to the company, the FDA says. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. The agency says to contact a health care provider for additional guidance.
If a product cannot be returned, the FDA says to dispose of it properly. If it is contaminated, the agency says to ensure it is in a secure container and to place it in a covered trash can or dumpster so no people or animals can access it, and to follow local disposal laws. The FDA also says to clean the area where the product was stored and not to give the product to others, such as a food bank or a pet.
A person experiencing an illness, injury, allergic reaction, or other adverse event should contact a health care provider or veterinarian, the FDA says, and can also report product issues to the FDA and the company that distributed the product. The agency encourages reports of issues involving FDA-regulated products through the FDA’s SmartHub. It also asks health professionals, patients, and consumers to report a product through MedWatch, which the agency calls the FDA Safety Information and Adverse Event Reporting Program. According to the FDA, a report can be filed on the internet, by telephone, or by sending the MedWatch 3500 form through the mail or by fax.