# US FDA Recalls & Safety Monitor (Food, Drug & Devices) (`b2b-quant-apis/us-fda-recalls-safety-monitor`) Actor

Monitors and enriches official U.S. FDA enforcement recall reports across Food, Drugs, and Medical Devices via openFDA. Calculates hazard severity scores (0-100) and generates Markdown legal briefs for Product Liability law firms and retail compliance.

- **URL**: https://apify.com/b2b-quant-apis/us-fda-recalls-safety-monitor.md
- **Developed by:** [Jesley Tassili de Oliveira Aguileira](https://apify.com/b2b-quant-apis) (community)
- **Categories:** AI, Business, News
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$30.00 / 1,000 us fda enforcement recall extracteds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## US FDA Recalls & Safety Enforcement Monitor (Food, Drug & Medical Devices)

Extract, score, and enrich official **U.S. Food and Drug Administration (FDA)** recall enforcement reports across **Food & Supplements**, **Drugs & Pharmaceuticals**, and **Medical Devices** directly from the official `openFDA` Enforcement API (`api.fda.gov`).

Designed for **Product Liability Law Firms**, **Mass Tort Litigation Intelligence**, **Retail & Grocery Supply Chain Compliance**, **Healthcare Procurement Teams**, and **AI Agents (MCP-Ready)**.

***

### Key Features

- **Multi-Domain FDA Enforcement Coverage**: Monitor `food`, `drug`, and `device` recall enforcement reports in a unified schema.
- **Quantitative Hazard Severity Scoring (`0-100`)**:
  - **Class I (`95-100`)**: Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  - **Class II (`70-75`)**: May cause temporary or medically reversible adverse health consequences.
  - **Class III (`40-45`)**: Not likely to cause adverse health consequences (e.g., minor labeling or packaging defects).
  - Dynamically adjusted by active `Ongoing` enforcement status and `Nationwide` distribution scope.
- **Automated Legal & Compliance Briefs (`markdownLegalBrief`)**: Every record includes a structured Markdown dossier ready for legal intake, mass tort evaluation, or vendor risk alerts.
- **Zero-Crash openFDA Query Engine**: Gracefully handles `HTTP 404` ("No matches found" in openFDA), malformed inputs, and fallback queries when complex search filters return empty matches.

***

### Input Parameters

| Field | Type | Default | Description |
| :--- | :--- | :--- | :--- |
| `domain` | `string` (`select`) | `"food"` | FDA category: `"food"`, `"drug"`, or `"device"`. |
| `classification` | `string` (`select`) | `"ALL"` | Severity filter: `"ALL"`, `"Class I"`, `"Class II"`, `"Class III"`. |
| `keyword` | `string` | `""` | Optional keyword searched in `reason_for_recall` or `product_description` (e.g., `"salmonella"`, `"listeria"`, `"undeclared"`). |
| `state` | `string` | `""` | Optional 2-letter US State code of the recalling firm (e.g., `"CA"`, `"NY"`, `"TX"`). |
| `maxResults` | `integer` | `15` | Number of enforcement records to retrieve (`1` to `200`). |

***

### Output Dataset Example

```json
{
  "recallNumber": "F-0912-2026",
  "eventId": "94102",
  "domain": "food",
  "classification": "Class I",
  "severityScore": 100,
  "recallingFirm": "Acme Organic Foods LLC",
  "city": "Los Angeles",
  "state": "CA",
  "country": "United States",
  "status": "Ongoing",
  "voluntaryMandated": "Voluntary: Firm initiated",
  "reportDate": "2026-03-15",
  "recallInitiationDate": "2026-03-01",
  "centerClassificationDate": "2026-03-12",
  "reasonForRecall": "Product has the potential to be contaminated with Salmonella.",
  "productDescription": "Organic Creamy Peanut Butter, 16 oz jars",
  "productQuantity": "14,200 cases",
  "codeInfo": "Lot #2026A14, Best By 12/2026",
  "distributionPattern": "Nationwide distribution across retail stores in the US.",
  "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF..."
}
```

# Actor input Schema

## `domain` (type: `string`):

Select the FDA enforcement category to monitor: food, drug, or device.

## `classification` (type: `string`):

Filter recalls by FDA hazard severity class (Class I = highest life-threatening risk, Class II = moderate/reversible risk, Class III = low risk).

## `keyword` (type: `string`):

Optional search keyword in reason_for_recall or product_description (e.g., 'salmonella', 'listeria', 'undeclared', 'pacemaker').

## `state` (type: `string`):

Optional 2-letter US State of recalling firm (e.g., 'CA', 'NY', 'TX', 'FL').

## `maxResults` (type: `integer`):

Maximum number of recall enforcement records to fetch (1 to 200).

## Actor input object example

```json
{
  "domain": "food",
  "classification": "ALL",
  "keyword": "",
  "state": "",
  "maxResults": 15
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("b2b-quant-apis/us-fda-recalls-safety-monitor").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("b2b-quant-apis/us-fda-recalls-safety-monitor").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call b2b-quant-apis/us-fda-recalls-safety-monitor --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,b2b-quant-apis/us-fda-recalls-safety-monitor"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/QfFlwX9MmzV4EetdS/builds/6GBlWNjuE4YNNz6sF/openapi.json