FDA Enforcement Reports versus FDA recall announcements
FDA actually publishes recall information in two different places, and they don't always agree on timing or coverage. Confusing the two is a common source of "why doesn't this match what I saw on FDA's site" questions, so this guide explains what each one is and how Public Health Trace uses both.
The Enforcement Report database
FDA's Enforcement Report database is the complete, structured record. By regulation (21 CFR 7.50), it includes every recall FDA monitors, classified as Class I, Class II, Class III, or "Not Yet Classified" while classification is pending. It's published on a weekly cadence and is the source Public Health Trace's drug recall data (openFDA) is built from.
The recall-announcement page
Separately, FDA's own Recalls, Market Withdrawals, & Safety Alerts page lists press releases and public notices about certain recalls -- narrative pages, usually written by (or with) the recalling company, that FDA posts as a public service. FDA says plainly that not all recalls have press releases or are posted on this page: a recall can be real, monitored, and fully present in the Enforcement Report without ever getting a narrative announcement page. Announcement pages are also archived off FDA's site after three years, while the underlying Enforcement Report entry remains the durable record.
Why a Public Health Trace record sometimes shows only one link
Public Health Trace's drug recall pages treat the structured openFDA Enforcement Report as the authoritative record, and separately ingest FDA's own announcement page as an early-warning source -- a newly announced recall can appear there days before the matching structured Enforcement Report entry exists. An announcement shown before it's matched to a structured record is clearly labeled as pending and never presented as an official enforcement record on its own. Once FDA's Enforcement Report entry exists, the page shows both: the Enforcement Report link (always) and the matched FDA announcement link (only when one was actually found) -- see methodology for the exact current rule.
What this means for you
If you're looking for a specific recall and can't find a narrative announcement page on FDA's site, that alone doesn't mean the recall isn't real -- check the Enforcement Report database directly, or search for it on Public Health Trace, where every drug recall record links back to its own source. This is Public Health Trace's own explanation of the distinction, not FDA's wording -- always verify the specific record against the official link on the page.
Limitations: this guide describes the general pattern as FDA's own pages document it. FDA occasionally changes how it archives or structures this data; if something here looks out of date, please report it.
Browse current records on Drug Recalls or the full Data Explorer.