The following information is directly from the USDA Food and Drug Administration's website and explains the basics of product recalls.
A recall is an action taken by a company to correct or remove from the market an FDA-regulated product that violates U.S. laws and regulations. Recalls may be initiated voluntarily by a company, or at the request of the FDA.
Recalls are important because they protect the public from products that may cause injury, illness or even death. More than 83,000 FDA-regulated products were recalled between 2014 and 2024.
Most recalls involve removing violative FDA regulated products from the market, but there are instances where a violation can be corrected without removing the products from distribution. For example:
- An MRI machine or other equipment may be too large to remove from a medical facility to correct a violation and the issue could be corrected on-site.
- Affixing updated labeling on a food product, prior to retail sale, to declare an ingredient previously not listed on the product’s labeling - such as wheat, milk or peanuts.
FDA-Regulated Products
- Human food products
- Animal food and feed
- Cosmetics
- Human drugs
- Animal drugs
- Medical devices
- Radiation-emitting products
- Vaccines
- Blood and blood products
- Transplantable human tissue
- Tobacco products
Common reasons a product may be recalled are:
- Manufacturing defects;
- Contamination with disease causing microorganisms such as Salmonella, E. coli, etc.;
- The presence of foreign objects such as broken glass, metal fragments or plastic;
- Failure to list a major allergen;
- Failure to list a certain ingredient;
- Risk of erroneous results when a product is used as directed, e.g., diagnostic testing product results being inaccurate;
- Non-sterile product intended to be sterile;
- Adverse event reports;
- Software corrections or updates.
Where Can Consumers Find Information About Recalls?
Enforcement Report: The FDA provides the public a descriptive listing of each new recall and, if classified, sorted by the recall’s classification in the FDA’s Enforcement Report.
Subscribe: The FDA offers a recall subscription serviceExternal Link Disclaimer where users can sign up to receive daily or weekly notification of all FDA recalls.
Public Warnings: are an effective way for companies or the FDA to alert the public that a product being recalled presents a serious health hazard. The FDA maintains a site, Recalls, Market Withdrawals, & Safety Alerts, of public warnings about certain recalls of FDA-regulated products. When a company announces a recall, market withdrawal, or safety alert, the FDA typically posts the company's announcement on its website as a public service. The FDA does not endorse either the product or the company.
To read more about this issue, visit the FDA Consumer Updates webpage