🚨 FDA Recall Intelligence — Drug, Device & Food Recalls with AI Risk Scoring

Extract FDA recall data — drugs, medical devices and food — from the official openFDA database as clean, structured rows with an AI intelligence score on every recall. Search across 80,000+ enforcement records by classification (Class I/II/III), company, product keywords and date range, then rank what matters by severity, recency and reach. Export to JSON/CSV/Excel, run on a schedule, call via API, or connect to Make, Zapier or n8n.

🚨 What is the FDA Recall Intelligence?

It turns the openFDA enforcement database into a structured, filterable dataset. Choose a product type and filters (severity class, firm name, keywords like "insulin" or "salmonella", and a date window) and it returns every matching recall with full detail — product description, reason, recalling firm, distribution and status — plus a transparent 0–100 intelligence score that surfaces the most serious, recent and widely-distributed recalls first. So compliance teams, pharmacies, hospitals, distributors and legal professionals can monitor safety risk without combing through the FDA site by hand.

What data does it extract?

• Product type (drug / device / food), description and recall classification
• Reason for recall and current status (e.g. ongoing / terminated)
• Recalling firm with city, state, country and postal code
• Recall number, initiation date, report date and termination date
• Distribution pattern and product quantity
• Regulatory detail — event ID, voluntary/mandated, firm notification, code info
• Drug fields when available — brand name, generic name, manufacturer name
• AI intelligence score (0–100) ranking each recall's severity and relevance

⬇️ Input

Every field is optional — leave them empty for all recent recalls, or narrow it down:

Field	Description
productType	all (drugs + devices + food), drug, device, or food
classification	Filter by severity, e.g. ["Class I"], ["Class I", "Class II"]; empty = all
keywords	Search product descriptions, e.g. ["insulin", "pacemaker", "salmonella"]
firmName	Recalling firm or manufacturer, e.g. Pfizer, Johnson & Johnson
dateFrom	Start of recall-initiation date range (YYYY-MM-DD)
dateTo	End of recall-initiation date range (YYYY-MM-DD)
maxResults	Cap the run (1–1000)
includeIntelligenceScore	Toggle the AI intelligence score on/off

Example input

{
  "productType": "drug",
  "classification": ["Class I", "Class II"],
  "keywords": ["insulin"],
  "dateFrom": "2025-01-01",
  "dateTo": "2026-06-26",
  "maxResults": 100,
  "includeIntelligenceScore": true
}

⬆️ Output

Every recall is one clean row (view as a table, or export JSON / CSV / Excel):

{
  "product_type": "drug",
  "product_description": "Insulin Glargine Injection 100 units/mL, 10 mL vial",
  "classification": "Class II",
  "status": "Ongoing",
  "recalling_firm": "Example Pharma Inc.",
  "city": "Trenton",
  "state": "NJ",
  "country": "United States",
  "postal_code": "08611",
  "reason_for_recall": "Product may contain particulate matter identified during stability testing.",
  "recall_number": "D-1234-2026",
  "recall_initiation_date": "20260115",
  "report_date": "20260205",
  "termination_date": null,
  "distribution_pattern": "Nationwide in the United States",
  "product_quantity": "12,400 vials",
  "event_id": "90876",
  "voluntary_mandated": "Voluntary: Firm initiated",
  "initial_firm_notification": "Letter",
  "code_info": "Lot #ABC123, Exp 2027-03",
  "center_classification_date": "20260130",
  "more_code_info": null,
  "brand_name": "Example Insulin",
  "generic_name": "insulin glargine",
  "manufacturer_name": "Example Pharma Inc.",
  "intelligence_score": 73
}

💡 Use cases

• ✅ Compliance & quality teams: monitor new recalls in your product categories and flag high-severity Class I events the day they post.
• 🏥 Pharmacies, hospitals & distributors: check whether drugs or devices you stock are affected and act on ongoing recalls fast.
• ⚖️ Legal & due diligence: research a company's recall history by firmName for litigation, M&A or supplier vetting.
• 🛡️ Supply-chain & consumer safety: track food recalls by keyword (e.g. salmonella, listeria) and distribution scope to assess exposure.

🧮 How the intelligence score works

A transparent 0–100 score combining four factors: classification severity (Class I > Class II > Class III, up to 50 pts), recency of the recall-initiation date (up to 25 pts), distribution scope (nationwide > regional > local, up to 15 pts) and status (ongoing recalls rank above terminated ones, up to 10 pts). Higher scores flag the most serious, recent and widely-distributed recalls — use it to triage and prioritize.

❓ FAQ

What recalls does it cover? FDA enforcement records for drugs, medical devices and food/cosmetics from the openFDA database — tens of thousands of recalls across all three categories. Use productType to focus on one or pull all of them.

How do I find the most serious recalls? Set classification to ["Class I"] (the most serious, risk of death or serious injury) and sort by the intelligence score, which already weights severity, recency and reach.

Can I search by company? Yes — set firmName to a manufacturer or recalling firm (e.g. Pfizer) to pull that company's recall history.

Can I filter by product or contaminant? Yes — keywords searches the product description, so terms like insulin, pacemaker or salmonella return matching recalls.

Can I limit to a date range? Yes — set dateFrom and/or dateTo (YYYY-MM-DD) to filter by recall-initiation date; leave both empty for all dates.

What is the intelligence score? A transparent 0–100 rating built from severity class, recency, distribution scope and status. Set includeIntelligenceScore to false if you don't need it.

Do I need an API key? No. It uses the public openFDA API — no key, login or authentication required.

Can I run it on a schedule or via API? Yes — schedule recurring runs in Apify, call it via the API/SDK, or connect it to Make, Zapier or n8n.

Is it legal? It collects publicly available recall data published by the FDA via the openFDA API. Use it responsibly for compliance, research and safety monitoring, and follow applicable laws.

🔗 You might also like

• openFDA Drug Intelligence — FDA drug label & data intelligence
• Vehicle Recalls Intelligence — NHTSA vehicle recalls

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