# FDA Recalls & Enforcement - Drugs, Devices, Food (`gmpsignal/fda-recalls-enforcement`) Actor

Official FDA recall and enforcement records for drugs, medical devices and food in one normalized feed. Filter by keyword, recalling firm, recall class, status, country, state and report date. ISO dates, class severity explained, no API key needed.

- **URL**: https://apify.com/gmpsignal/fda-recalls-enforcement.md
- **Developed by:** [GMPSignal](https://apify.com/gmpsignal) (community)
- **Categories:** News, Automation, AI
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $2.00 / 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.

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

## FDA Recalls & Enforcement Actions — Drugs, Medical Devices & Food

Extract official US Food and Drug Administration (**FDA**) recall enforcement reports from the **openFDA Enforcement API** covering **Drugs**, **Medical Devices**, and **Food** products.

Monitor Class I, II, and III recalls, recalling firms, lot/serial numbers (`codeInfo`), reason for recall, product quantities, nationwide/international distribution patterns, and recall status.

***

### Data Sources

Queries the official openFDA Enforcement endpoints directly:

- **Drugs:** `https://api.fda.gov/drug/enforcement.json`
- **Medical Devices:** `https://api.fda.gov/device/enforcement.json`
- **Food & Beverages:** `https://api.fda.gov/food/enforcement.json`

#### FDA Recall Classifications

| Classification | Severity | Meaning |
|---|---|---|
| **Class I** | Critical | Dangerous or defective products that predictably could cause serious health problems or death. |
| **Class II** | Moderate | Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. |
| **Class III** | Minor | Products that are unlikely to cause any adverse health reaction, but violate FDA labeling or manufacturing laws. |

***

### Input Parameters

| Parameter | Type | Default | Description |
|---|---|---|---|
| `categories` | `string[]` | `["drug", "device", "food"]` | FDA enforcement categories to query (`drug`, `device`, `food`). |
| `searchQuery` | `string` | `""` | Keyword searched across `product_description` and `reason_for_recall` (e.g. `"salmonella"`, `"sterility"`, `"undeclared"`). |
| `firm` | `string` | `""` | Filter by recalling firm name (`recalling_firm`), e.g. `"Pfizer"`, `"Medtronic"`, `"Abbott"`. |
| `classification` | `string` | `"all"` | Filter by hazard severity: `"all"`, `"Class I"`, `"Class II"`, or `"Class III"`. |
| `status` | `string` | `"all"` | Filter by enforcement status: `"all"`, `"Ongoing"`, `"Completed"`, `"Terminated"`, or `"Pending"`. |
| `country` | `string` | `""` | Filter by recalling firm country (e.g. `"United States"`, `"India"`, `"Canada"`). |
| `state` | `string` | `""` | Filter by 2-letter US state code (e.g. `"CA"`, `"NJ"`, `"TX"`). |
| `dateFrom` | `string` | `"2026-01-01"` | Earliest `report_date` (`YYYY-MM-DD`). |
| `dateTo` | `string` | `""` | Latest `report_date` (`YYYY-MM-DD`). Leave empty for today. |
| `maxItems` | `integer` | `500` | Maximum total enforcement records to output across all selected categories (`1`–`25000`). |
| `proxy` | `object` | *(optional)* | Optional Apify Proxy configuration. |

#### Example Input

```json
{
  "categories": ["drug", "device", "food"],
  "classification": "Class I",
  "status": "Ongoing",
  "dateFrom": "2026-01-01",
  "maxItems": 200
}
```

***

### Output Format

Each dataset item contains structured enforcement metadata, OpenFDA brand/generic/manufacturer enrichments, and formatted dates (`YYYY-MM-DD`):

```json
{
  "category": "food",
  "recallNumber": "F-0412-2026",
  "eventId": "95812",
  "status": "Ongoing",
  "classification": "Class I",
  "classificationMeaning": "Dangerous or defective products that predictably could cause serious health problems or death.",
  "recallingFirm": "Example Foods LLC",
  "brandNames": "NatureHarvest",
  "genericNames": null,
  "manufacturerNames": "Example Foods LLC",
  "productType": "Food",
  "productDescription": "Organic Creamy Peanut Butter, 16 oz (454g) glass jars, UPC 0-12345-67890-1",
  "productQuantity": "14,200 cases",
  "reasonForRecall": "Product has the potential to be contaminated with Salmonella.",
  "voluntaryOrMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "Press Release",
  "distributionPattern": "Distributed nationwide in the US to retail grocery stores.",
  "city": "Fresno",
  "state": "CA",
  "country": "United States",
  "postalCode": "93721",
  "address": "1200 Industrial Way",
  "recallInitiationDate": "2026-02-10",
  "centerClassificationDate": "2026-02-24",
  "reportDate": "2026-03-04",
  "terminationDate": null,
  "codeInfo": "Lot codes: NH2601A, NH2601B; Best By 01/2027",
  "sourceUrl": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0412-2026%22",
  "scrapedAt": "2026-04-17T10:00:00.000Z"
}
```

***

### Use Cases

- **Healthcare & Hospital Supply Chain Compliance:** Automatically cross-reference hospital inventory and pharmacy formularies against ongoing Class I & II drug and medical device recalls.
- **Food & Grocery Retail Quality Assurance:** Track undeclared allergen alerts, *Listeria*/*Salmonella*/*E. coli* recalls, and affected lot numbers (`codeInfo`).
- **Pharmaceutical & MedTech Competitive Intelligence:** Analyze enforcement history by manufacturer (`firm`), state/country, or failure mode (e.g., cGMP deviations, sterility, particulate matter).
- **Automated Risk & Legal Monitoring:** Schedule daily runs with `dateFrom` to feed new FDA enforcement actions into compliance workflows.

***

### Notes

- **Automatic Pagination:** Seamlessly paginates through openFDA results in batches of 100 up to `maxItems`.
- **Clean Normalized Dates:** Converts FDA's raw `YYYYMMDD` dates into standard ISO `YYYY-MM-DD` strings.

# Actor input Schema

## `categories` (type: `array`):

Which openFDA enforcement datasets to query: drugs, medical devices and/or food.

## `searchQuery` (type: `string`):

Free-text search across product description, reason for recall and recalling firm, e.g. "sterility", "metformin", "listeria".

## `firm` (type: `string`):

Filter by the company that issued the recall, e.g. "Pfizer", "Abbott". Partial names work.

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

FDA severity class. Class I is the most serious (risk of serious injury or death).

## `status` (type: `string`):

Current status of the recall as reported by the FDA.

## `country` (type: `string`):

Country of the recalling firm, e.g. "United States", "India", "Germany".

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

Two-letter US state code of the recalling firm, e.g. "CA", "NJ", "TX".

## `dateFrom` (type: `string`):

Earliest FDA report date, format YYYY-MM-DD. Leave empty for no lower bound.

## `dateTo` (type: `string`):

Latest FDA report date, format YYYY-MM-DD. Leave empty for no upper bound.

## `maxItems` (type: `integer`):

Maximum number of recall records to store in the dataset.

## `proxy` (type: `object`):

Optional proxy. The openFDA API is public and usually reachable without one.

## Actor input object example

```json
{
  "categories": [
    "drug",
    "device",
    "food"
  ],
  "classification": "all",
  "status": "all",
  "dateFrom": "2026-01-01",
  "maxItems": 500
}
```

# 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 = {
    "categories": [
        "drug",
        "device",
        "food"
    ],
    "dateFrom": "2026-01-01",
    "maxItems": 500
};

// Run the Actor and wait for it to finish
const run = await client.actor("gmpsignal/fda-recalls-enforcement").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 = {
    "categories": [
        "drug",
        "device",
        "food",
    ],
    "dateFrom": "2026-01-01",
    "maxItems": 500,
}

# Run the Actor and wait for it to finish
run = client.actor("gmpsignal/fda-recalls-enforcement").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 '{
  "categories": [
    "drug",
    "device",
    "food"
  ],
  "dateFrom": "2026-01-01",
  "maxItems": 500
}' |
apify call gmpsignal/fda-recalls-enforcement --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,gmpsignal/fda-recalls-enforcement"
        }
    }
}
```

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/fGm9hJYuzi75jrRnQ/builds/4JQPbFhYt8ihxMN8y/openapi.json