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Reference Libraries

openFDA Drug Enforcement API Documentation Dataset

openFDA Drug Enforcement API Documentation Dataset

19,00 €

Explore structured openFDA drug-enforcement API documentation with section-level text, source references and an archived edition.

Purchase terms

Your purchase includes the edition described on this page. Later releases are separate unless this offer explicitly includes an update entitlement.

Source checks and new-release publication do not change the historical coverage or automatically add future editions to an earlier purchase.

Edition details

Edition
zf-038-2026-09-05-303720933634
Files
data/full.jsonl, data/full.csv, data/sample.json, schema.json, provenance.json, manifest.json, quality-report.json, LICENSE.md, README.md, CHANGELOG.md, sources/original-document.html, checksums.json
Formats
CSV, HTML, JSON, JSONL, MD
Coverage
Structured documentation snapshot of openFDA drug enforcement docs, retrieved 2026-09-05. Records are document sections and paragraphs; the original publisher HTML is included.
Geographic scope
Structured documentation snapshot of openFDA drug enforcement docs, retrieved 2026-09-05. Records are document sections and paragraphs; the original publisher HTML is included.
Publisher
open.fda.gov
Source updated
Explicitly unknown; see immutable provenance for the recorded source retrieval.
Source checked
2026-09-05T12:07:45.440238+00:00
Released
2026-09-05T12:07:45.440238+00:00
Licence and attribution
Source records remain subject to the original publisher terms linked in provenance.json. Retain attribution and source notices. Zentra grants use of the normalization, schema and packaging for internal and commercial analysis; this does not grant exclusive rights over public source facts or third-party material. No endorsement by source publishers.

View the publisher source

Schema

FieldTypeDescription
elementstring
sectionstring
section_record_idinteger
source_urlstring
textstring

Sample preview

Open the public sample

elementsectionsection_record_idsource_urltext
pDrug Enforcement Overview1https://open.fda.gov/apis/drug/enforcement/The openFDA drug enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly.
pDrug Enforcement Overview2https://open.fda.gov/apis/drug/enforcement/The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in Chapter 7 of FDA’s Regulatory Procedure Manual The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
liKey Facts3https://open.fda.gov/apis/drug/enforcement/Source of the data:FDA Recall Enterprise System (RES)
liKey Facts4https://open.fda.gov/apis/drug/enforcement/Changes to the source data:openFDA annotates the original records with special fields and converts the data into JSON, which is a widely used machine readable format.
liKey Facts5https://open.fda.gov/apis/drug/enforcement/Time period covered in this API:2004 to null
pFields Harmonization6https://open.fda.gov/apis/drug/enforcement/Different datasets use different unique identifiers, which can make it difficult to find the same drug in each dataset.
pFields Harmonization7https://open.fda.gov/apis/drug/enforcement/openFDA features harmonization on specific identifiers to make it easier to both search for and understand the drug products returned by API queries. These additional fields are attached to records in all categories, if applicable.
pFields Harmonization8https://open.fda.gov/apis/drug/enforcement/Review the chart below to better understand which fields are harmonized.
Category:

Keep the drug-enforcement API reference in a structured offline format for integration research and internal documentation. The captured sections can be indexed or reviewed alongside their source information without presenting documentation text as recall events.

What this download contains

This product is separate from the drug recall enforcement export. The text extraction excludes navigation and scripts, and its section boundaries may differ from the visual organisation of the original page. The release identifies the captured reference scope.

Working with this edition

Inspect the sample and use source references when checking a parameter or response description. Compare with the live documentation before changing a production collector, particularly when service behaviour has evolved since the archived edition.

Product questions

Does this include drug recall records?

No. It contains the API documentation rather than the operational recall dataset.

Is it clinical guidance?

No. Technical API reference material is not medical or treatment advice.

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