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FDA EnforcementFDA Enforcement Reports (Drug + Device Recalls)
U.S. Food & Drug Administration (openFDA) · Tier-1 · research-only (never on individual profiles)
The openFDA enforcement feeds publish drug and device recall enforcement reports — the recalling firm, recall classification (Class I–III), reason for recall, distribution pattern, and status. Fonteum folds the drug and device enforcement partitions into one source keyed by recall number and product kind.
How this source shows up on Fonteum.
Aggregate research context on drug and device recalls, keyed to the recalling firm. The firm name is normalized so an Open Payments manufacturer organization can be cross-referenced in a separate, gated follow-up; that entity-graph link is deferred and ambiguous matches are held, not written.
What this source does NOT mean
A recall enforcement report is an FDA action about a product and the firm that distributed it — it is not a statement about any healthcare provider, not a quality measurement, and not a Fonteum assessment. A named firm is not an asserted identity match to any provider profile.
Research and data questions this source supports.
- Pull every drug and device recall enforcement report for a manufacturer in one query, keyed to the recalling firm name.
- Build a recall-monitoring feed that flags new Class I recalls weekly as openFDA republishes the enforcement partitions.
- Cross-reference a manufacturer's recall history against its Open Payments footprint for a supply-chain risk review.
- Power a research surface on recall classification and reason-for-recall trends across drug and device categories.
Dataset size: 56,777 recall records (2026-06-14 snapshot)
Per-field display contract.
Fields listed below show their configured `display_allowed` flag from the §94 provenance schema. Fields marked write-locked are captured for audit and are not rendered on profile pages.
Research-only — never on profiles
6 fieldsWhat we can’t infer from this source.
- Tier-1 — aggregate research context only; never rendered on individual provider profiles.
- Firm-keyed by name (normalized); there is no NPI in the source, and the entity-graph cross-link to Open Payments manufacturers is deferred — ambiguous matches are held, not written.
- openFDA omits empty fields; some legacy recalls carry sparse dates or classifications.
- A recall record reflects the FDA enforcement action as published; Fonteum does not adjudicate the underlying facts.
Authority, license, publisher cadence.
Authority
U.S. Food & Drug Administration (openFDA)
Tier
Tier-1 · research-only (never on individual profiles)
Publisher / configured cadence
Declared or configured cadence: Weekly — openFDA republishes the enforcement partitions. Not evidence of the latest loaded source date.
License
openFDA — CC0 public domain (U.S.-government works). Free to use; no API key required for bulk downloads. License ↗
Official URL
Attribution requirement
Source: U.S. Food & Drug Administration (openFDA) — Enforcement Reports · Snapshot {YYYY-MM-DD}
What the source allows.
openFDA data is CC0 public domain. No API key is required for bulk downloads; attribution to openFDA / the U.S. Food & Drug Administration is the courtesy ask. Snapshot and attestation fields must be read from the specific artifact; no provenance fact currently links deterministically to a signature.
What a single field looks like in the graph.
This worked example shows the provenance shape used when a surfaced field has populated source, last-checked, display-rule, and confidence metadata. Individual fields may omit unavailable values.
Field
Recall enforcement report (research-only)
Sample value
Recall Z-0000-2025 · Class II · Reason: labeling mix-up · Ongoing
Provenance line
Source: openFDA Enforcement · Snapshot 2026-06-14 · Methodology fda-enforcement/v1 · Display rule: firm-keyed research context — never an asserted provider-identity match
Official API, bulk download, and Fonteum endpoints.
Official API / download
Fonteum surface
Common questions about FDA Enforcement.
- What is the openFDA enforcement (recall) dataset?
- The openFDA enforcement feeds publish drug and device recall enforcement reports — the recalling firm, recall classification (Class I, II, or III), reason for recall, distribution pattern, and status. Fonteum folds the drug and device enforcement partitions into one source keyed by recall number and product kind.
- Where does this data come from and is it free?
- It comes from the openFDA enforcement API (api.fda.gov). openFDA data is CC0 public domain (U.S.-government works) — free to use and redistribute with attribution, and no API key is required for bulk downloads.
- Is a recall linked to a healthcare provider?
- No. Enforcement reports are keyed to the recalling firm (a manufacturer or distributor), not to any healthcare provider. The firm name is normalized so an Open Payments manufacturer organization can be cross-referenced in a separate, gated follow-up; that entity-graph link is deferred and ambiguous matches are held, not written.
- What do the recall classifications mean?
- FDA assigns Class I (reasonable probability of serious harm or death), Class II (temporary or reversible harm), or Class III (unlikely to cause harm) to each recall. The classification reflects FDA's assessment of the product hazard, not a Fonteum judgment.
- How often does the data refresh?
- openFDA republishes the enforcement partitions on a roughly weekly cadence. Loaded dates must be read from the specific response; publisher cadence is not proof of a completed load. As of the 2026-06-14 snapshot, Fonteum holds 56,777 enforcement records.
Where this source already shows up.
Related sources in the graph
- /sources → The generated source-catalog subset — documented datasets Fonteum cites.
- /data-provenance → The provider graph — pipeline diagram, source-family clusters, field-level provenance examples, display rules.
- /methodology → Documented sourcing, publisher cadence, observed freshness, and corrections policy.
- /editorial-policy → Independence, sourcing, conflicts, corrections, retractions.