FDA Enforcement Report Overview
What is the FDA Enforcement Report?
The FDA Enforcement Report is FDA's public weekly list of the product recalls it monitors. On FDA's own wording, "All recalls monitored by FDA are included in the Enforcement Report once they are classified" (FDA, Enforcement Reports).
What it covers
- Products: recalls across every FDA-regulated product type: food, drugs, devices, biologics, cosmetics, animal products, tobacco and radiation-emitting products.
- What each entry gives: the recall classification, the reason for the recall, code information (such as lot numbers) and a description of the product.
- Classification: each recall is listed as Class I, Class II, Class III or "not yet classified." FDA says that "most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health."
- Pending recalls: since June 2017 the report has also listed recalls that are "not yet classified." This gives the public early notice while FDA finishes its hazard assessment.
- How to get it: through the weekly report, FDA's quick and advanced search, and an API.
When a recall appears A recall usually shows up in the report later than the firm's own announcement. FDA notes that "recalls often occur well before the FDA completes its classification process and subsequently posts to this report." So a firm's press release or recall notice can come out weeks before the Enforcement Report entry.
Approach: I read FDA's official Enforcement Reports page. The datasets I can search also hold the FDA's food and drug enforcement recall records (one record per recall number), so I can look up specific recalls there.
If useful, I can pull specific food or drug recalls by firm, product, classification or date range.
How do I search it for food recalls?
To find food recalls, go to FDA's Enforcement Report application, open Search Enforcement Reports (the advanced search) and set Product Type to Food. You can then narrow the results by class, firm, reason, date and other fields (FDA, Enforcement Report Navigation and Definitions).
Step by step (FDA's interface)
- Pick how you want to look. FDA offers three routes: "View Weekly Enforcement Reports" to browse each week's report by year and month, "Search Enforcement Reports" for custom searches, and the Archived Enforcement Reports link for older data.
- Filter the advanced search. You can filter by Product Description, Code Information, Product Type, Recall Class, Recalling Firm, Status, Recall Number, Reason for Recall, Classification Date and Event ID. Some useful food searches:
- Reason for Recall with a word like "Listeria", "Salmonella" or "undeclared" plus the allergen, to find a hazard.
- Code Information to check a lot number or best-by code.
- Recall Class = Class I to see only the highest-risk recalls.
- Find pending recalls. Choose "Not Yet Classified" under Recall Class. Those records have no classification date yet, so FDA notes the classification date fields can't be used for them.
- Choose a view or export. Product View is the default and gives one line per product with "VIEW DETAILS". Event View groups all the products in one recall event. Print View splits results into tabs by product category. CSV Export downloads the results as a spreadsheet file.
Reading the results
- Recall Number is FDA's ID for one classified recalled product. Event ID identifies the whole recall event, which can cover several recall numbers.
- Center Classification Date is the date FDA classified the recall as Class I, II or III.
- Status is On-Going, Completed (the firm has retrieved all the product it can recover) or Terminated (FDA has decided reasonable recall efforts are complete).
Other ways in
- API: the Enforcement Report API gives access to the data "without the need to use the user interface" (API documentation).
- Email alerts: Subscribe to Recalls sends notifications filtered by product category, keyword or product type (FDA, Enforcement Reports).
Approach: I read FDA's Enforcement Reports page and its Navigation and Definitions page. The datasets I can search also hold FDA's food recall records, searchable by firm, class, status, report or start date and recall text, but I couldn't run a sample search of them this time.
If you give me a firm, a hazard (such as Listeria or an undeclared allergen) or a date range, I can search those food recall records for you.