# FDA Recall Risk Records — openFDA Enforcement (`nexgensignal/fda-recall-risk-records`) Actor

FDA recall/enforcement records from openFDA (food, drug, device) — firm, product, classification, reason, distribution, status. openFDA unvalidated-results disclaimer carried. No API key. Pay per record. Part of NexGen Signal — official-source data products.

- **URL**: https://apify.com/nexgensignal/fda-recall-risk-records.md
- **Developed by:** [NexGen Signal](https://apify.com/nexgensignal) (community)
- **Categories:** Business, News, Other
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $33.50 / 1,000 recall records

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

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

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
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.
Actors are written with capital "A".

## 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.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## FDA Recall Risk Records — openFDA Enforcement

**Official source. No API key. Pay per record.**

This actor turns the U.S. FDA's recall/enforcement data (via openFDA) into clean, per-recall records across **food, drug, and device**. Each run reads the official openFDA enforcement endpoints and delivers one record per recall — the recalling firm, the product, the classification (Class I/II/III), the reason, the distribution pattern, and the status — with openFDA's own accuracy disclaimer carried on every record.

### What this is, in one paragraph

The FDA publishes recall and enforcement actions for food, drugs, and medical devices. This actor reads them through openFDA's keyless API and flattens each into a row: who recalled, what product, why, how serious (classification), where it was distributed, and the current status. Values are verbatim. Because openFDA explicitly labels its data as unvalidated, that disclaimer travels on every record.

### Who buys this and for what job

- **Supply-chain, QA, and compliance teams** screening suppliers and products against FDA recalls across food/drug/device in one feed.
- **Risk and insurance analysts** tracking recall classification and reasons over time.
- **Researchers and journalists** who need the structured recall facts with firm and product detail.
- **Data engineers** wanting a keyless, one-call recall feed.

### openFDA disclaimer (carried verbatim)

openFDA labels its data as unvalidated. This actor carries that disclaimer, exactly as published, on every record and in this listing:

> "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

These are recall records for information and screening — not medical, legal, or safety advice.

### Pricing

| Event | Free plan | Bronze | Silver | Gold / Platinum / Diamond |
|-------|-----------|--------|--------|---------------------------|
| `recall_record` | $0.05 | $0.045 | $0.04 | $0.0335 |

Delivered before charged. Blocked runs and empty results cost nothing.

### Input

| Field | Type | Default | Description |
|-------|------|---------|-------------|
| `endpoints` | string list | food, drug, device | Which openFDA enforcement datasets to pull. |
| `sinceDate` | string (YYYYMMDD) | — | Optional. Keep recalls with a report date on or after this date. |
| `classification` | select | Any | Optional recall classification filter (Class I/II/III). |
| `maxRecords` | integer | 500 | Ceiling on records delivered and billed. |

The actor paces requests under openFDA's published rate limit.

### Output

One JSON object per recall. Example:

```json
{
  "record_id": "D-1234-2026:drug",
  "endpoint": "drug",
  "recall_number": "D-1234-2026",
  "status": "Ongoing",
  "classification": "Class II",
  "product_type": "Drugs",
  "recalling_firm": "Example Pharma Inc.",
  "product_description": "Example Tablets 10mg",
  "reason_for_recall": "Failed dissolution specification",
  "distribution_pattern": "Nationwide",
  "voluntary_mandated": "Voluntary: Firm Initiated",
  "recall_initiation_date": "20260710",
  "report_date": "20260805",
  "state": "NJ", "country": "United States", "city": "Trenton",
  "source": "openFDA (FDA enforcement / recalls)",
  "openfda_disclaimer": "Do not rely on openFDA ... assume all results are unvalidated ...",
  "licence": "openFDA — U.S. FDA. Public-domain U.S. Government data ...",
  "attribution": "Source: U.S. FDA openFDA",
  "observed_at": "2026-08-18T00:00:00Z"
}
```

An unbilled `RUN_RECEIPT` records the robots check, endpoints, the disclaimer seen, records seen/delivered, and whether charged equals delivered.

### Cost guidance

One `recall_record` per delivered recall: cost = recalls pulled × your plan's per-record price. 1,000 recalls is **$50** (Free) / **$33.50** (Gold). The full enforcement corpus across the three endpoints is roughly 87,000 records.

### Honest limitations

- **Unvalidated by the source.** openFDA states results are unvalidated; treat as informational and verify against FDA.
- **Recalls only.** This is the enforcement/recall dataset — not approvals, adverse events, or launches.
- **Firm-level.** Records are firm/product level; there is no person data.
- **Rate-limited.** Runs pace under openFDA's published limit; very large pulls take longer.

### Differentiation

Distinct from the NexGenData recall/launch products: fleet-1's **cpsc-product-recalls** covers a **different agency** (U.S. CPSC consumer products, not FDA food/drug/device), and fleet-2's **product-launch-alerts** covers launches, which are the opposite of recalls. This actor is FDA recalls specifically.

### The NexGen Signal family

Part of the NexGen Signal family of official-source, pay-per-record products:

- [Eurostat House Price Index](https://apify.com/nexgensignal/eurostat-house-price-index)
- [Eurostat Waste Generation](https://apify.com/nexgensignal/eurostat-waste-generation)
- [Eurostat Waste Treatment](https://apify.com/nexgensignal/eurostat-waste-treatment)
- [Eurostat Business & Consumer Confidence](https://apify.com/nexgensignal/eurostat-business-confidence)
- [Eurostat Income Distribution (EU-SILC)](https://apify.com/nexgensignal/eurostat-income-distribution)
- [Eurostat Construction Production](https://apify.com/nexgensignal/eurostat-construction-production)
- [Eurostat Immigration Statistics](https://apify.com/nexgensignal/eurostat-immigration-statistics)
- [Eurostat Emigration Statistics](https://apify.com/nexgensignal/eurostat-emigration-statistics)
- [Eurostat Road Freight Transport](https://apify.com/nexgensignal/eurostat-road-freight)
- [Organization Sanctions & LEI Risk](https://apify.com/nexgensignal/organization-sanctions-lei-risk)

*Source: U.S. FDA via openFDA (public-domain U.S. Government data, https://open.fda.gov/license/). Reformatted to recall records; values verbatim. openFDA's "results are unvalidated" disclaimer is carried on every record.*

# Actor input Schema

## `endpoints` (type: `array`):

Which openFDA enforcement datasets to pull: food, drug, and/or device.

## `sinceDate` (type: `string`):

Optional. Keep only recalls with a report\_date on or after this date.

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

Optional recall classification filter.

## `maxRecords` (type: `integer`):

Maximum records delivered and billed. You are billed only for records delivered.

## Actor input object example

```json
{
  "endpoints": [
    "food",
    "drug",
    "device"
  ],
  "classification": "",
  "maxRecords": 500
}
```

# Actor output Schema

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

The delivered FDA recall/enforcement records.

# 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 = {
    "endpoints": [
        "food",
        "drug",
        "device"
    ],
    "maxRecords": 500
};

// Run the Actor and wait for it to finish
const run = await client.actor("nexgensignal/fda-recall-risk-records").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 = {
    "endpoints": [
        "food",
        "drug",
        "device",
    ],
    "maxRecords": 500,
}

# Run the Actor and wait for it to finish
run = client.actor("nexgensignal/fda-recall-risk-records").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 '{
  "endpoints": [
    "food",
    "drug",
    "device"
  ],
  "maxRecords": 500
}' |
apify call nexgensignal/fda-recall-risk-records --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,nexgensignal/fda-recall-risk-records"
        }
    }
}

```

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/BbgSGVkUDK0jmj6dJ/builds/QaUFoHC6ofSiLbb70/openapi.json