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U.S. Department of Health and Human Services

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Recalls - Considerations

View PDF of the Recalls Section (61 KB)


Background 

Summary of Public Comments 

Transparency Report Arrow Considerations

View All Recalls Draft Proposals


Considerations

The Task Force considered FDA’s limited authority with respect to recalls of FDA-regulated products and the extent to which that has hampered FDA’s ability to quickly analyze and address potential risks posed by a defective or otherwise violative product.  Except in limited circumstances (which affect a limited number of FDA-regulated products), FDA generally does not have the authority to require manufacturers and/or distributors to recall products or to provide FDA with information about recalls of products.  Additional disclosure of information by industry about defective or otherwise violative products that are being recalled may improve FDA’s ability to assess the risk associated with a recall more rapidly.

The Task Force considered how FDA could most effectively communicate the risk associated with the defective product.  The Task Force considered the amount of control FDA has over the message that is communicated to the public about the recall.  The Task Force took into account the importance of communicating to the public that the risk has passed following an effective recall.

The Task Force also considered whether the information associated with FDA’s recall classification decision—e.g., Class I, Class II, or Class III recall—would provide useful, understandable, actionable information to the public.