Methodology

How this works

Global coverage

All companies in openFDA drug enforcement records are indexed, regardless of country. Each record preserves the original country field from the FDA source. Records with missing country data appear as "Country not recorded."

Matching

Recall records are attached to companies using exact normalized name matching against a unique alias, scoped by country. If a name maps to multiple companies, it is marked as ambiguous and not attached automatically. We do not use fuzzy matching, substring matching, or model-generated links.

Identity

Currently all companies are name-provisional because the openFDA enforcement endpoint does not expose FEI numbers. When FEI data becomes available, companies will be promoted to fei_verified status and merged deterministically.

Source

The index uses openFDA drug/enforcement.json for all countries. Import refusal data (originally planned from openFDA import_refusal.json) is deferred because that endpoint does not currently exist in the openFDA API. The FDA Data Dashboard has import refusal data but requires authentication for API access.

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, FEI, legal entity, safety, compliance, or approval.