"The Food and Drug Administration (FDA) is responsible for safeguarding the Nation's food supply by ensuring that all ingredients are safe and free from disease-causing organisms, chemicals, or other harmful substances. No statute existed prior to 2011 to authorize FDA to require manufacturers/processors or importers to recall food except for infant formula. When a problem arises with a particular food, the manufacturer/processor or importer may voluntarily recall the product. FDA established regulations that are explicit in that the regulations are nonbinding guidance that FDA and the recalling firm should consider in planning and implementing a recall. This report refers to these regulations as 'recall guidance.' The recall guidance specifies that when a firm initiates a recall, FDA should assess the seriousness of the health hazard that the recalled product poses and assign a recall classification of Class I, II, or III. Class I indicates the greatest health hazard. The recall guidance also specifies the elements of the firm's recall process that FDA should monitor and assess in determining the adequacy of the firm's recall. These elements include recall initiation, recall strategy, recall communications, recall status reports, and product disposal."
Department of Health and Human Services, Office of Inspector General, Report No. A-01-09-01500
Department of Health and Human Services, Office of the Inspector General: http://oig.hhs.gov/