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  1. Recalls, Market Withdrawals, & Safety Alerts

Enforcement Reports

What is the Enforcement Report?

All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.

Recall data in the Enforcement Report can be accessed through the weekly report publication, the quick and advanced search functionalities, and an Application Programming Interface (API). The recall information can also be seen under a number of different views.

Instructions for navigating the report, accessing and using the API, and definitions of the report contents are found on the Enforcement Report Navigation and Definitions page.

 

How do I subscribe to the Enforcement Report mailing list?

The FDA Enforcement Report application subscription service allows individuals to register for e-mail notifications of new and updated FDA recalls posted to the application. Users can choose to be notified of all recalls, commodity specific recalls (i.e., Food, Devices, Drugs, etc.), or recalls based on keywords. These keywords can be product specific, such as "cPAP" or "dog food", brand name, or by reason for recall, such as "peanut" or "sterility". Users can also choose to subscribe to individual recall events on a daily or weekly basis.

To subscribe, use this link or access the Enforcement Report application and click on the "Subscribe to Recalls/Manage Preferences" at the top of the page.

 

What is a pending recall classification?

On June 15, 2017, as part of a larger effort to increase transparency, empower consumers, and enhance public health, the Enforcement Report began listing recalls pending classification, or “not yet classified” recalls, in addition to classified recalls, to alert the public sooner whenever a product has been recalled.

In these instances, the FDA has determined that a firm’s action meets the definition of a recall however the FDA has not completed its assessment of the hazard posed by the recalled product(s) yet – this is considered a pending classification. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s). This initiative allows FDA to post certain recalls to the Enforcement Report sooner since the Agency is no longer waiting for the hazard assessment to be completed.

 

What is the History feature?

The Enforcement Report tracks and displays updates to a recall’s Classification, Reason for Recall, Code Information, and Product Description if changes occur after initial publication. This update history is available for all recalls posted or updated beginning July 24, 2018 and forward.

Information for how these changes will appear and what parts of the Enforcement Report are effected can be found on the Enforcement Report History Feature page.

 

How are recalls categorized in the Enforcement Reports?

FDA considers a recall to be a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. Separate from determining whether a firm’s action meets the definition of a recall, FDA also classifies a particular product recall to indicate the relative degree of health hazard (class I, II, or III) presented by the product being recalled. Recalls are categorized in the Enforcement Report as either class I, II, or III or "not yet classified."

 

How else does FDA provide early notification about recalls?

FDA is conducting a trial pilot program to expedite notifications of Non-Blood (HCT/P, Vaccine, Derivative, etc.) product recalls to the public which can be found at Non-Blood Product On-Going Recalls.
 

 

Where do I find additional resources about Enforcement Reports?

For information gathered from press releases and other public notices about certain recalls of FDA-regulated products, you can visit Recalls, Market Withdrawals, & Safety Alerts.

An additional enforcement tool is the Import Alert, which informs FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. More information can be found at Import Alerts.

 

What if I have additional questions about Enforcement Reports?

Please e-mail [email protected] with any comments.

 

 

 

 

 

 



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