How to read an FDA recall record
A food or drug recall record on Public Health Trace is built entirely from fields FDA itself publishes -- nothing here is Public Health Trace's own judgment about whether a product is unsafe. This guide explains what each part of that record means, in plain language, so you can use it the way it was intended: to check whether a product you have matches a real recall.
What FDA actually calls this
FDA defines a recall as a firm's action to remove a product from the market, or correct it, because it violates a law FDA enforces. A recall can start three ways: the firm recalls voluntarily on its own, FDA asks the firm to recall, or -- rarely -- FDA orders a recall under its statutory authority. This is different from a market withdrawal (a minor problem FDA wouldn't take legal action over) and, for medical devices, a safety alert (issued when a device may pose an unreasonable risk of substantial harm). Public Health Trace follows FDA's own terminology rather than inventing its own -- see FDA's own Recalls Background and Definitions page.
The fields that matter for checking a product
Whatever else a recall record shows, FDA's own consumer guidance boils down to the same handful of fields: the brand name, the product description (including package size), and any lot codes, UPC, or expiration/best-by dates printed on the product itself. A recall almost never applies to "everything with this name forever" -- it applies to specific production runs, which is exactly what lot codes and dates identify. If a Public Health Trace recall page doesn't show a lot code or package size for a given record, that means the source feed we imported it from hasn't published that field yet, not that the real recall has no such detail -- see methodology's known limitations for exactly which gaps are currently real.
Classification: Class I, II, or III
FDA assigns every recall it classifies a Roman-numeral class describing how serious the health risk is, not how large the recall is:
- Class I
- A reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
- Class II
- The product may cause temporary or medically reversible harm, or the probability of serious harm is remote.
- Class III
- The product is not likely to cause an adverse health consequence (for example, a labeling error or defective packaging unrelated to safety).
- Not Yet Classified
- FDA classifies a recall after the firm supplies risk information -- until that happens, the record shows this instead of a class.
Classification doesn't change what you should do with the product, and it doesn't delay or excuse the firm's own obligation to act -- it's FDA's own description of risk severity, published after the fact.
Status: what "ongoing," "completed," and "terminated" mean
A recall record also carries a status. See what recall statuses mean for the full explanation of each term FDA uses and what Public Health Trace shows when a source hasn't published a status at all.
Where this data comes from
Food and drug recall records on Public Health Trace are imported from FDA's structured openFDA enforcement data and, for some drug recalls, FDA's own recall-announcement page. See FDA Enforcement Reports versus FDA recall announcements for how those two differ and why a record sometimes links to both.
What this guide is, and isn't
This is Public Health Trace's own plain-language explanation of how to read a recall record -- it is not FDA's own wording, and it is not medical advice. Public Health Trace does not tell you whether to discard, return, or keep using a specific product; FDA's own recall notice and Recalls, Market Withdrawals, & Safety Alerts page are the authoritative source for that. See our medical disclaimer for what this site is not.
Limitations: not every importer captures lot codes or package sizes yet (see methodology), and some sources (USDA FSIS, FDA's RSS feed) don't publish a status or classification at all. Where a field is missing, Public Health Trace says so rather than guessing.
Browse current records on Drug Recalls, Health Alerts, or the full Data Explorer.