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OpenFDA — Drug Recalls, Adverse Events & Labels

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$1.00 / 1,000 dataset item scrapeds

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OpenFDA — Drug Recalls, Adverse Events & Labels

OpenFDA — Drug Recalls, Adverse Events & Labels

Search FDA drug recalls, adverse event reports (FAERS), and drug label information via the OpenFDA API. Filter by drug name, recall class, state, date range, and reaction type. No API key required.

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$1.00 / 1,000 dataset item scrapeds

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Harry Schoeller

Harry Schoeller

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Search FDA drug safety data via the OpenFDA public API. Three modes: enforcement actions (recalls), adverse event reports (FAERS), and drug label information.

Modes

enforcement (default) — Drug recalls & market withdrawals

{
"mode": "enforcement",
"classification": "Class I",
"startDate": "2023-01-01",
"maxRecords": 200
}

adverse-events — FAERS adverse event reports

{
"mode": "adverse-events",
"drugName": "metformin",
"seriousOnly": true,
"startDate": "2022-01-01",
"maxRecords": 500
}

labels — Drug label / prescribing information

{
"mode": "labels",
"drugName": "lisinopril",
"maxRecords": 10
}

Example output record (enforcement)

{
"recall_number": "D-1234-2023",
"status": "Ongoing",
"recalling_firm": "ABC Pharmaceuticals Inc.",
"reason_for_recall": "Out of specification results for potency",
"classification": "Class II",
"product_description": "Metformin HCl Tablets, 500mg",
"state": "NJ",
"recall_initiation_date": "20230315",
"distribution_pattern": "Nationwide",
"fetchedAt": "2025-01-01T00:00:00.000Z"
}

Recall classifications

  • Class I — Serious health risk or death possible
  • Class II — Temporary adverse health effects
  • Class III — Unlikely to cause adverse effects

Use cases

  • Drug safety monitoring and pharmacovigilance
  • Supply chain and pharmacy compliance
  • Healthcare provider risk alerts
  • Insurance and liability research
  • Academic drug safety research