FDA oversees product recalls to protect public health. It first learns of potential product issues through company reports, inspections, or reports to the CDC. FDA then works with companies on voluntary recalls and publicizes high risk recalls through press releases and updates on its website. It monitors companies' corrective actions until recalls are complete to ensure unsafe products are removed from the market.

1. Consumer Health Information
www.fda.gov/consumer
FDA 101: Product Recalls
From First Alert to Effectiveness Checks
First Alert Alerting the Public Effectiveness Checks
FDA hears about product problems FDA posts regular updates about FDA reviews all of a company’s
through company notification, recalls to its Web site, and all corrective actions to determine
agency inspections and adverse recalls appear in the agency’s when a recall is complete.
event reports, and through CDC. weekly Enforcement Reports.
O
nce a product is in widespread use, unforeseen problems recall. But in every case, FDA’s role is
can sometimes lead to a recall. Contaminated spinach, to oversee a company’s strategy and
assess the adequacy of the recall.
for example, led to the recent recall of spinach products
under multiple brand names. Contaminated peanut butter led to First Alert
the recall of thousands of jars of two popular brands. In both FDA first hears about a problem
cases, FDA responded immediately to minimize harm. product in several ways:
• A company discovers a problem
and contacts FDA.
When an FDA-regulated product is rather than from an intentional dis- • FDA inspects a manufacturing
either defective or potentially harm- regard for the law. facility and determines the
ful, recalling that product—removing Recalls are almost always volun- potential for a recall.
it from the market or correcting the tary. Sometimes a company discovers • FDA receives reports of health
problem—is the most effective means a problem and recalls a product on its problems through various
for protecting the public. In most own. Other times a company recalls reporting systems.
cases, a recall results from an unin- a product after FDA raises concerns. • The Centers for Disease Control and
tentional mistake by the company, Only in rare cases will FDA request a Prevention (CDC) contacts FDA.
Illustrations: FDA/Michael Ermarth
1 / FDA Consumer Health Information / U.S. Food and Drug Administration OC TOBER 2009

2. Consumer Health Information
www.fda.gov/consumer
RECAll ClASSIFICATIOnS These guidelines categorize all recalls into one of three classes,
according to the level of hazard involved:
Class I Dangerous or defective products that predictably could cause serious health problems or death.
Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label
mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II Products that might cause a temporary health problem, or pose only a slight threat of a serious
nature. Example: a drug that is under-strength but that is not used to treat life-threatening
situations.
Class III Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or
manufacturing laws. Examples include: a minor container defect and lack of English labeling in a
retail food.
When it comes to illnesses associ- complete after all of the company’s cor-
ated with food products, Dorothy J. rective actions are reviewed by FDA
Miller, Director of FDA’s Office of
FDA-regulated Products and deemed appropriate. After a recall
Emergency Operations, says that FDA Subject to Recall is completed, FDA makes sure that the
generally first hears of these kinds of • human drugs product is destroyed or suitably recondi-
problems from CDC. tioned, and investigates why the product
“CDC hears about such problems • animal drugs was defective in the first place.
from state health departments that
• medical devices
have received and submitted illness
reports,” she says. “An ongoing out- • radiation-emitting products This article appears on FDA’s
break means that we have an emer- Consumer Updates page (www.fda.
• vaccines
gency, and when there’s a public gov/ForConsumers/ConsumerUpdates),
health crisis like this, you need to tell • blood and blood products which features the latest on all FDA-
the public immediately.” regulated products.
• transplantable human tissue
Alerting the Public • animal feed For More Information
FDA seeks publicity about a recall only FDA 101: Product Recalls (video)
when it believes the public needs to • cosmetics www.fda.gov/ForConsumers/
be alerted to a serious hazard. When • about 80 percent of the ConsumerUpdates/ucm182929.htm
a recalled product has been widely foods eaten in the United
distributed, the news media is a very Protect Your Health Joint FDA/
effective way to reach large numbers
States WebMD resource
of people. FDA can hold press confer- www.webmd.com/fda/default.htm
ences, issue press releases, and post
updates to its Web site regularly, to Not all recalls are announced in the Archive for Recalls, Market
alert people. media. But all recalls go into FDA’s Withdrawals & Safety Alerts
“It’s about being as transparent as weekly Enforcement Report. This www.fda.gov/Safety/Recalls/
possible,” says Catherine McDermott, document lists each recall according ArchiveRecalls/default.htm
public affairs manager in the Division to classification (see “Recall Classifi-
of Federal-State Relations in FDA’s cations” box), with the specific action Food Safety Alerts and Tips Widget
Office of Regulatory Affairs. “If we taken by the recalling firm. www.foodsafety.gov/widgets/index.html
feel there is that much of a health
risk, we will offer media updates Effectiveness Checks FoodSafety.gov: Your Gateway to
every day to give new information, FDA evaluates whether all reasonable Federal Food Safety Information
and all that we know gets posted to efforts have been made to remove or www.foodsafety.gov/
FDA’s Web site.” correct a product. A recall is considered
Illustrations: FDA/Michael Ermarth
2 / FDA Consumer Health Information / U.S. Food and Drug Administration OC TOBER 2009