Safety

Enforcement Report Definitions

Whereas not all recalls are announced in the media or on FDA's Recalls press release page, all recalls go into FDA's Enforcement Report once they are classified according to the level of hazard involved. FDA continues 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 entitled FDA 101: Product Recalls that provides an 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 and interpret the Enforcement Report.

HOW TO NAVIGATE THE REPORT

FDA recall information can be accessed on the enforcement report site by selecting the "View Weekly Enforcement Reports" button, the new "Search Enforcement Reports" (i.e., Advanced Search) button, or the Archived Enforcement Reports link.

Within the weekly enforcement report section, users are able to access weekly reports by first selecting the desired year and month on the pull down menus and clicking on the links that correspond to the report week of interest.

Users are also able to retrieve tailored reports via the "Search Enforcement Reports" (i.e., Advanced Search) section by selecting specific or a combination of criteria including; Product Description, Code Information, Product Type, Recall Class, Recalling Firm, Status, Recall Number, Reason for Recall, Classification Date, or Event ID.

Upon accessing the desired weekly or tailored report, users have four different ways to view recall information: Product View, Event View, Print View (only available under the weekly reports section), and Export to CSV.

The default view for the Enforcement Report is the Product View. This view displays recall information by product. To retrieve additional information about the recalled product, select the "VIEW DETAILS" link. A recall event may include more than one recalled product.

An alternate view of the Enforcement Report recall information will be the Event View. To choose this view, select the "View by Event" link to the right of the "View by Product" displayed under the page title. To retrieve additional information about a recall event, select the "VIEW DETAILS" link.

The ”Print View” (FIGURE 1) displays all the recall information for each Product Type, separated into tabs by commodity, on one page allowing users to more easily cut and paste information relevant to their needs.

 

FIGURE 1: Sample PRINT VIEW

iRes Print Screen

Archived Enforcement Reports can be accessed by selecting the link in the left-hand navigation box on the Enforcement Report home page. This section allows access to the enforcement reports published from January 2004 through mid-June 2012.

 

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.

Distribution Pattern - General area of initial distribution such as states, countries, or territories; 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 Information - 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.

Recall Initiation Date - The date 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.

Center Classification Date - The date that FDA classified the recall as Class I, II, or III.

Date Terminated – The date that FDA terminated the recall.

Page Last Updated: 03/11/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English