FDA Enforcement Reports: What They List, How Recalls Are Classed, and How to Search Them

General regulatory information for laboratory, clinic and supply staff, not legal or medical advice.

Short answer

The FDA Enforcement Report is the agency’s public listing of recalls it monitors, each shown as Class I, II, III or “Not Yet Classified.” Under 21 CFR 7.50 FDA lists each new recall in the weekly report, and the same data can be searched by product, firm, recall number or lot information. It leaves out firm actions that FDA judges to be market withdrawals or stock recoveries.

Definition and scope

FDA’s Enforcement Report page says the report “includes all recalls monitored by FDA to include Class I, II, III, or ‘not yet classified’.” Its search covers seven product types: biologics, food, cosmetics, tobacco, devices, veterinary and drugs. The regulation behind it, 21 CFR 7.50, says FDA will promptly make available in the weekly FDA Enforcement Report “a descriptive listing of each new recall according to its classification.”

Press releases and public notices are a separate source. They sit on FDA’s Recalls, Market Withdrawals, & Safety Alerts page, not in the Enforcement Report.

How the report is used in practice

FDA’s search page offers three routes: the weekly reports, an advanced search, and an API with its own documentation. Results can be shown by product or by event, since one recall event can include more than one product. A print view exists only for weekly reports, and results can be exported to CSV.

Search fields and what each one answers

Field	What FDA says it is	Why a lab or clinic would use it
Product Description	Brief description of the product	Find an item by name
Code Information	Lot and/or serial numbers, product numbers, expiration or use-by dates as they appear on the product or labeling	Compare against the lot and catalog numbers on the label of a product you hold
Recalling Firm	The firm that initiates a recall	List recalls by a manufacturer
Recall Number	Alphanumeric designation FDA assigns to a specific classified recalled product, for tracking	Cite one product’s entry in records
Event ID	Numerical designation FDA assigns to a specific recall event, for tracking	Group every product in the same event
Reason for Recall	How the product is defective	Understand the defect behind the entry
Recall Class and Status	Classification I, II, III or Not Yet Classified; progress of the recall	Filter by hazard level or open recalls

Quick search accepts words or combinations of words, exact phrases in double quotes, and dates in mm/dd/yyyy form. FDA states the oldest date available is 06/08/2012. To find a recall that is not yet classified, choose “Not Yet Classified” under Recall Class; those records have no classification date, so the classified date fields are disabled.

Classes and status values

FDA assigns the class to show the relative degree of health hazard (21 CFR 7.41). The definitions on FDA’s Enforcement Report definitions page are:

• Class I: a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II: use or exposure may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
• Class III: use or exposure is not likely to cause adverse health consequences.

The Status field shows recall progress: On-Going (in progress), Completed (the firm has retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or completed all corrections) and Terminated (FDA has determined that all reasonable efforts were made to remove or correct the product). A separate field marks a recall as voluntary (started by the firm on its own, or after FDA requested it) or mandated (started under statutory recall authority, a court order or an FDA order).

What the Enforcement Report does not tell you

This is the part most summaries skip. Each limit below comes from FDA’s own text.

If you expect…	What the sources say
Every firm action on a product	21 CFR 7.50: the report “will not include a firm’s product removals or corrections” that FDA determines to be market withdrawals or stock recoveries. FDA defines a market withdrawal as a minor violation that would not be subject to FDA legal action.
Same-day news of a recall	FDA says classification usually comes after the firm supplies the information needed to judge the risk, and firms often warn the public well before FDA classifies and posts. Posting is not a change to the firm’s voluntary warning.
Every drug and device to appear promptly	21 CFR 7.50: FDA will intentionally delay public notification of recalls of certain drugs and devices where it determines notification may cause unnecessary and harmful anxiety in patients.
The full chain of customers	Distribution Pattern is the general area of initial distribution (states, countries, territories); later distribution by consignees to other parties may not be included.

Where it matters for labs, clinics and supply decisions

The Code Information field is the one that connects a report entry to physical stock, since it lists lot or serial numbers, product numbers and dates as printed on the product or its labeling. One way to use the report with the fields FDA documents:

1. Search by Product Description or Recalling Firm and set Product Type to Devices (or Drugs, Biologics and so on) as needed.
2. Open the entry and read Code Information, Reason for Recall and Recall Class.
3. Compare Code Information with the lot and catalog numbers on the labels of products you hold.
4. Record the Recall Number and Event ID in your own records, because FDA designates them for tracking.
5. Note the Status value, which FDA defines as On-Going, Completed or Terminated.

For the bigger picture of how FDA sorts recalls, see the CASRAI comparison FDA recall classes I, II and III. For related FDA lookup tools, see the guides to the FDA inspection database, the FDA product classification database and field safety corrective actions, and the term medical device reporting (MDR).

Common misunderstandings

• “If it is not in the report, there was no recall action.” Market withdrawals and stock recoveries are outside the report by regulation, and unclassified recalls appear as “Not Yet Classified.”
• “Class III means ignore it.” Class III is defined as not likely to cause adverse health consequences; it is still a recall FDA monitors and lists.
• “A listing means the firm only just announced the recall.” The listing follows FDA classification, and the Recall Initiation Date field records when the firm first began notifying the public or its consignees.
• “Terminated means the product is safe.” Terminated means FDA determined that all reasonable efforts had been made to remove or correct the product under the recall strategy.

FAQ

What is an FDA enforcement report?

It is FDA’s public listing of recalls it monitors, classified as Class I, II or III or shown as not yet classified, published weekly under 21 CFR 7.50 and searchable online.

How often is the FDA enforcement report issued?

The regulation calls it the “weekly FDA Enforcement Report,” and FDA’s site provides weekly reports by year and month.

Where can I find the FDA enforcement reports?

On FDA’s Enforcement Report site (accessdata.fda.gov/scripts/ires), through the weekly reports, the advanced search or the API. Press releases are on the separate Recalls, Market Withdrawals, & Safety Alerts page.

Sources

• FDA, Enforcement Report search: https://www.accessdata.fda.gov/scripts/ires/index.cfm (checked 2026-11-01).
• FDA, Enforcement Report information and definitions: https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions (checked 2026-11-01).
• FDA, Recalls background and definitions: https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions (checked 2026-11-01).
• 21 CFR 7.50, public notification of recall: https://www.law.cornell.edu/cfr/text/21/7.50 (checked 2026-11-01).
• 21 CFR 7.41, health hazard evaluation and recall classification: https://www.law.cornell.edu/cfr/text/21/7.41 (checked 2026-11-01).