Clinical Trial SignalopenFDA recall monitoring.
Daily monitoring of FDA Drug Enforcement records via the openFDA API — recall classification, scope, affected lots, and reason for recall, surfaced as soon as the public record is posted.
What openFDA Drug Enforcement is
openFDA's Drug Enforcement endpoint exposes the FDA's structured recall record — the same record published in the FDA Enforcement Report. Each entry includes the recalling firm, product description, classification (Class I, II, or III), distribution pattern, lot numbers, code information, reason for recall, and status (ongoing, completed, terminated).
What Clinical Trial Signal monitors
New recall postings
Class I, II, III classification
Affected lots and distribution
Status updates
Why it matters
Recall classifications are watched closely by supply chains, prescribers, payers, and competitors. A Class I recall on a marketed product can disrupt supply for weeks and create temporary share opportunity for therapeutic alternatives — but reading the lot scope, distribution pattern, and reason for recall is essential to scoping impact.
Who uses openFDA recall monitoring
Client supply-chain briefs
Competitor and partner recalls
Source-linked recall reporting
Class and reason aggregation
Source caveats
openFDA Drug Enforcement records reflect the FDA's classification at posting and may be revised. Classification does not itself establish causation of harm. Lot scope and distribution pattern can be updated. Clinical Trial Signal reports what the public record shows; it does not infer clinical impact or product safety beyond the FDA's stated classification.
Start tracking openFDA recalls
Free includes the latest openFDA recalls. Pro adds daily recall briefs, watchlists, and export. Analyst Desk adds wire-feed cross-reference.