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FDA Drug, Device & Food Recall Enforcement & Legal Lead API

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Extract official US FDA Class I, II & III drug, medical device, and food recall enforcement actions (openFDA) into clean JSON/CSV. Get Recalling Firm Names, HQ Addresses, Recall Reasons, Severity Classes & Product Quantities. Built for mass-tort law firms, quant funds, n8n & MCP AI.

Pricing

from $5.00 / 1,000 extracted fda recall records

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Mehdad Sharifi

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15 hours ago

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FDA Drug, Medical Device & Food Recall Enforcement & Legal Lead Scraper API

Extract official US Food and Drug Administration (openFDA Enforcement) Class I, Class II, and Class III product recalls and safety enforcement actions across Pharmaceuticals (DRUG), Medical Devices (DEVICE), and Food and Beverages (FOOD) directly into clean JSON, CSV, or Excel datasets.

Built for mass-tort and product liability law firms, short-selling hedge funds, supply-chain QA and regulatory compliance teams, n8n and Make automation workflows, and AI agents (Claude MCP and Cursor)—with zero proxy fees required.

Why Choose This FDA Drug, Device & Food Recall Scraper?

Feature	What You Get
Multi-Domain FDA Recall Coverage	Switch seamlessly between FDA Drug Enforcement (DRUG), Medical Device Enforcement (DEVICE), and Food Enforcement (FOOD) recall databases in one unified API.
Class I, II & III Severity Filtering	Isolate critical Class I life-threatening recalls from moderate Class II or minor Class III labeling recalls with a single filter.
Recalling Manufacturer B2B Details	Captures the exact Recalling Firm Name, physical street address, city, state, postal code, country, voluntary vs. FDA-mandated status, and nationwide distribution pattern.
Exact Recall Reason & Product Quantity	Extracts the detailed root-cause defect or contamination reason (reasonForRecall), full product description, and total number of affected units or lots.
Zero Proxy or API Key Costs	Connects directly to official US Government api.fda.gov endpoints—blazing fast and zero residential proxy costs.

What Data Does This Actor Extract? (Sample JSON Output)

Every FDA recall enforcement action is structured into a clean, flat JSON record:

{
  "recallNumber": "Z-1842-2026",
  "productDomain": "DEVICE",
  "recallingFirm": "CARDIAC RHYTHM MEDICAL SYSTEMS INC.",
  "classification": "Class I",
  "severitySignal": "CLASS I (Critical / Life-Threatening Risk - High Litigation & Stock Catalyst)",
  "status": "Ongoing",
  "reportDate": "2026-10-14",
  "recallInitiationDate": "2026-09-22",
  "reasonForRecall": "Potential premature battery depletion in implantable pacemaker pulse generators may result in sudden loss of pacing therapy.",
  "productDescription": "Model 4200 Implantable Dual-Chamber Pacemaker Pulse Generator",
  "productQuantity": "14,250 units",
  "voluntaryOrMandated": "Voluntary: Firm initiated",
  "distributionPattern": "Nationwide in the US and internationally to EU and Canada",
  "address1": "4500 MEDTECH PARKWAY",
  "city": "MINNEAPOLIS",
  "state": "MN",
  "postalCode": "55413",
  "country": "US",
  "matchedQuery": "Pacemaker"
}

How to Use FDA Recall Enforcement & Legal Lead Scraper

Select FDA Recall Domain: Choose DRUG (Pharmaceuticals & Biologics), DEVICE (Medical Devices & Diagnostics), or FOOD (Food, Beverages & Dietary Supplements).
Enter Search Keywords or Company Names: Add one or more defect keywords, device types, or manufacturer names (e.g., Pacemaker, Infusion, Sterile, Contamination, Abbott, Baxter).
Filter by Severity Class: Choose ALL, or isolate CLASS_I_HIGHEST_RISK for the most severe product recalls.
Set Max Recall Records: Choose how many recall enforcement records to extract per run (default: 30, up to 500+).
Run & Export: Click Start and download your dataset in JSON, CSV, Excel, or XML, or connect directly via the Apify REST API.

FDA Recall Severity Classifications Reference

FDA Class	Official Risk Definition	Commercial & Trading Signal
Class I	Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.	Highest Signal — Primary lead source for mass-tort plaintiff law firms and a major bearish stock catalyst for public manufacturers.
Class II	Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.	Moderate Signal — Ideal for B2B regulatory remediation consultants, GMP auditing firms, and contract manufacturing (CMO) outreach.
Class III	Use of, or exposure to, a violative product is not likely to cause adverse health consequences (typically minor packaging or labeling defects).	Low Signal — Used for supply-chain quality benchmarking and packaging vendor outreach.

Transparent Pay-Per-Event Pricing

You only pay for the exact FDA recall records extracted:

Actor Startup (apify-actor-start): USD 0.01 per run.
Extracted FDA Recall (fda-recall-extracted): USD 0.005 per parsed FDA recall enforcement record (USD 5.00 per 1,000 recalls).
Free Tier Friendly: With Apify's free USD 5.00 monthly credit, you can extract nearly 1,000 FDA recall enforcement records every month for free.

Top Use Cases

Mass-Tort & Product Liability Law Firms: Automatically monitor new Class I medical device and pharmaceutical recalls (such as implantable devices, surgical mesh, infusion pumps, or contaminated drugs) to identify high-value mass-tort litigation campaigns early.
Short-Selling & Healthcare Equity Research: Track material FDA enforcement actions against public MedTech, pharma, and consumer packaged goods (CPG) companies before quarterly earnings calls.
B2B QA, Sterilization & Regulatory Consulting Leads: Reach out to recalling manufacturers with GMP remediation consulting, third-party lab testing, or contract sterilization services right when they need compliance help.
Hospital & Pharmacy Supply-Chain Monitoring: Automate daily recall checks in n8n or Make to alert hospital procurement teams when medical devices or drugs in their inventory are recalled.

Frequently Asked Questions (FAQ)

Where does this FDA recall data come from?

All records are extracted directly from the official U.S. Food and Drug Administration (openFDA) Weekly Enforcement Reports across the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Food Safety and Applied Nutrition (CFSAN).

What is the difference between a Class I and Class II FDA recall?

A Class I recall is the most urgent and severe FDA enforcement action, issued only when a defective drug, medical device, or food product poses a reasonable probability of serious injury or death. A Class II recall involves products that may cause temporary or medically reversible health issues.

How can I connect this FDA Recall API to Python, Google Sheets, Clay, or n8n?

You can trigger this Actor via the Apify REST API, the apify-client Python or Node.js SDK, or the native Apify integration node inside n8n, Make, Clay, and Zapier to automatically route recall alerts to Slack, Telegram, Google Sheets, or your CRM.

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