Changes

Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.

Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.

== First Alert ==

== First Alert ==

FDA first hears about a problem product in several ways:

FDA first hears about a problem product in several ways:

== Alerting the Public ==

== Alerting the Public ==

FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.

FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.

Not all recalls are announced in the media. But all recalls go into FDA's weekly Enforcement Report. This document lists each recall according to classification (see "Recall Classifications" box), with the specific action taken by the recalling firm.

Not all recalls are announced in the media. But all recalls go into FDA's weekly Enforcement Report. This document lists each recall according to classification (see "Recall Classifications" box), with the specific action taken by the recalling firm.

== Effectiveness Checks ==

== Effectiveness Checks ==

FDA evaluates whether all reasonable efforts have been made to remove or correct a product. A recall is considered complete after all of the company's corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.

FDA evaluates whether all reasonable efforts have been made to remove or correct a product. A recall is considered complete after all of the company's corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.

== Recall Classifications ==

== Recall Classifications ==

These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:

These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:

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.

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.

== FDA-regulated Products Subject to Recall ==

== FDA-regulated Products Subject to Recall ==

* human drugs

* human drugs

* about 80 percent of the foods eaten in the United States

* about 80 percent of the foods eaten in the United States

[[Category:FDA]][[Category:Health]]

[[Category:FDA]][[Category:Health]]