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U.S. Department of Health and Human Services

Safety

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Enforcement Report Definitions

Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls go into FDA's Enforcement Report once they are classified according to the level of hazard involved.  In the new report, FDA will continue its pilot program expediting notifications of human drug product recalls to the public.  Drug Products will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action.  

FDA published a consumer update and video in May 2010 entitled FDA 101:  Product Recalls that provides a good explanation of the recall process and provides guidelines for recall classifications and descriptions of FDA-regulated products subject to recall.  Please read on for instructions describing How to Navigate the Report and How to Interpret the Report. 

HOW TO NAVIGATE THE REPORT

Users have five different ways to retrieve FDA's recall information:  Product View, Event View, Print-Friendly View, Pending and Download CSV.  These views are accessible by selecting links displayed horizontally below the page title and the date of the report.  Enhanced functionality of the report includes:

  • Users can sort the table by Product Description, Code Info, Classification, Reason for Recall, and Recalling Firm. 
  • Users interested in only seeing recall information related to a specific Product Type (e.g., Biologics, Devices, Drugs, Food/Cosmetics, and Veterinary) can select the tab representing the products for which they are interested. 
  • To download the entire dataset, select the "Download CSV" link located to the right of the "More Info" link.  Please note that if you choose to open the file in Excel, due to character limitations for each cell, the Code Information and Product Description may run over into the next cell, causing formatting issues in the spreadsheet.
  • The "More Info" link displays this explanatory page.
  • The "Pending" link includes information about human drug recall actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action.

The new default view for the Enforcement Report is the PRODUCT VIEW (See Figure 1). This view displays recall information by product.  To retrieve additional information about the recalled product, select the Product Description.  The resulting detail page will display additional information about the recalled product along with information associated with the Recall Event.  A recall event may include more than one recalled product.  

FIGURE 1: Sample PRODUCT VIEW

 Enforcement Report - Product View

 
An alternate view of the Recall information will be the EVENT VIEW (FIGURE 2). To choose this view, select the EVENT VIEW link to the right of the PRODUCT VIEW displayed under the page title and breadcrumb navigation links that appear horizontally below the title. Like the PRODUCT VIEW, users will be able to sort by the column headings or select a Product Type tab to narrow down the list. To retrieve additional information about a recall event, select the Event Details.
 

FIGURE 2: Sample EVENT VIEW

 Enforcement Report

 

The PRINT-FRIENDLY VIEW (FIGURE 3) displays all the recall information for a Product Type on one page allowing users to more easily cut and paste information relevant to their needs.  

 

FIGURE 3: Sample PRINT-FRIENDLY VIEW

Enforcement Report 

 

HOW TO INTERPRET THE REPORT - REPORT LABEL DEFINITIONS

 
Recalling Firm -  The firm that initiates a recall or, in the case of an FDA requested recall or FDA Mandated recall, the firm that has primary responsibility for the manufacture and (or) marketing of the product to be recalled.
 
Classification - Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard.
 
  • 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.

Status – Monitoring classification to evaluate the progress of a recall action. 

  • On-Going - A recall which is currently in progress.
  • Completed - The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections. 
  • Terminated - FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
  • Pending - Actions that have been determined to be recalls, but that remain in the process of being classified. 

Distribution Pattern - General area of initial distribution such as, “Distributors in 6 states: NY, VA, TX, GA, FL and MA; the Virgin Islands; Canada and Japan”. The term “nationwide” is defined to mean the fifty states or a significant portion.  Note that subsequent distribution by the consignees to other parties may not be included.  

Product Description - Brief description of the product being recalled.
 
Code Info - A list of all lot and/or serial numbers, product numbers, packer or manufacturer numbers, sell or use by dates, etc., which appear on the product or its labeling.
 
Reason for Recall - Information describing how the product is defective and violates the FD&C Act or related statutes.
 
Product Quantity - The amount of defective product subject to recall.
 
Voluntary/Mandated -  Describes who initiated the recall. Recalls are almost always Voluntary, meaning initiated by a firm. A recall is deemed Voluntary when the firm voluntarily removes or corrects marketed products or FDA requests the marketed products be removed or corrected.  A recall is Mandated when the firm was ordered by the FDA to remove or correct the marketed products, under section 518(e) of the FD&C Act, National Childhood Vaccine Injury Act of 1986, 21 CFR 1271.440, Infant Formula Act of 1980 and its 1986 amendments, or the Food Safety Modernization Act (FSMA).  
 
Recall Initiation Date - The date (format YYYY-MM-DD) that the firm first began notifying the public or their consignees of the recall.
 
Initial Firm Notification of Consignee or Public - The method(s) by which the firm initially notified the public or their consignees of a recall. A consignee is a person or firm named in a bill of lading to whom or to whose order the product has or will be delivered.
 
Recall Number – An alphanumeric designation assigned by FDA to a specific recalled product used for tracking purposes.
 
Event ID - A numerical designation assigned by FDA to a specific recall event used for tracking purposes.

 

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