# FDA Recalls & Adverse Events API: Drug, Device, Food (`clearpathdata/openfda-recalls-adverse-events`) Actor

Pull FDA drug, device and food recalls (enforcement reports) and adverse event reports (FAERS, MAUDE, CAERS) from the official openFDA API with simple filters. $2.50 per 1,000 records.

- **URL**: https://apify.com/clearpathdata/openfda-recalls-adverse-events.md
- **Developed by:** [Six Figure Salute](https://apify.com/clearpathdata) (community)
- **Categories:** Business, Automation
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$2.50 / 1,000 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 & Adverse Events API: Drug, Device, Food

Pull FDA drug, device and food recalls (enforcement reports) and adverse event reports (FAERS, MAUDE, CAERS) from the official openFDA API with simple filters. $2.50 per 1,000 records.

### What does it do?

**FDA Recalls & Adverse Events** pulls recalls (enforcement reports) for drugs, devices and food, and adverse event reports (**FAERS**, **MAUDE**, **CAERS**) from the official **openFDA** API, with simple keyword, firm and date filters.

- ✅ Official public data source: no login, no cookies, no proxies
- ✅ Fast: plain API calls, typical runs finish in seconds
- ✅ Clean, flat JSON / CSV / Excel output, ready for Sheets, BI tools or AI agents
- ✅ Pay only for results: no monthly rental

### Use cases

- **Quality & regulatory teams:** monitor recalls in your product category.
- **Pharmacovigilance:** pull adverse events for a drug.
- **Retail & food safety:** alert on food recalls.

### How to use it

1. Click **Try for free**. The input is prefilled with a working example.
2. Edit the input (see examples below) and click **Start**.
3. Download results as JSON, CSV, Excel or HTML, or pull them via API.

### Input examples

**Insulin drug recalls**

```json
{
  "dataset": "drug-recalls",
  "keyword": "insulin",
  "maxItems": 20
}
```

### Output

Sample rows:

| recall_number | recalling_firm | classification | status | reason_for_recall | report_date |
|---|---|---|---|---|---|
| D-0806-2026 | Baxter Healthcare Corporation | Class II | Ongoing | CGMP Deviations | 20260909 |
| D-0524-2026 | Central Admixture Pharmacy Services, Inc (CAPS)  Los Angeles | Class II | Ongoing | Incorrect Product Formulation: product did not contain insul… | 20260513 |
| D-0445-2024 | Eli Lilly & Company | Class II | Completed | CGMP Deviations | 20240424 |

Sample JSON record (long fields shortened):

```json
{
  "found": true,
  "endpoint": "drug/enforcement",
  "status": "Ongoing",
  "city": "Deerfield",
  "state": "IL",
  "country": "United States",
  "classification": "Class II",
  "openfda": {
    "application_number": [
      "BLA208157"
    ],
    "brand_name": [
      "MYXREDLIN"
    ],
    "generic_name": [
      "INSULIN HUMAN"
    ],
    "manufacturer_name": [
      "Baxter Healthcare Corporation"
    ],
    "product_ndc": [
      "0338-0126"
    ],
    "product_type": [
      "HUMAN PRESCRIPTION DRUG"
    ]
  },
  "product_type": "Drugs",
  "event_id": "99500",
  "recalling_firm": "Baxter Healthcare Corporation",
  "address_1": "1 Baxter Pkwy",
  "address_2": "N/A",
  "postal_code": "60015-4625",
  "voluntary_mandated": "Voluntary: Firm initiated",
  "initial_firm_notification": "Letter",
  "distribution_pattern": "US Nationwide; Puerto Rico; and Chile.",
  "recall_number": "D-0806-2026",
  "product_description": "MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfie...",
  "product_quantity": "N/A",
  "reason_for_recall": "CGMP Deviations",
  "recall_initiation_date": "20260806",
  "center_classification_date": "20260828",
  "report_date": "20260909",
  "code_info": "Lot # NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, Exp Date: 12/31/2027; Lot # NC193719, NC193849, Exp Date: 04/30/2028; L...",
  "more_code_info": "",
  "source": "openFDA api.fda.gov/drug/enforcement; unvalidated FDA data, not for clinical decisions"
}
```

### Pricing

Pay per event: **$0.0025 per record** ($2.50 per 1,000). No start fee, no monthly rental. Rows for not-found inputs and errors are free.

| Results | Cost |
|---|---|
| 100 records | $0.25 |
| 1,000 records | $2.50 |
| 10,000 records | $25.00 |

Apify's free plan includes monthly platform credit, so you can try it at no cost.

### Integrations

- **Google Sheets:** use Apify's Google Sheets integration, or import the dataset CSV link with `=IMPORTDATA()`.
- **Zapier & Make:** trigger runs and receive the dataset via the official Apify apps.
- **Webhooks & schedules:** run daily or hourly and post results anywhere.
- **AI agents (MCP):** available to Claude, ChatGPT and other agents through the Apify MCP server.
- **API & SDKs:** call from Python, JavaScript or any HTTP client:

```bash
curl -X POST 'https://api.apify.com/v2/acts/clearpathdata~openfda-recalls-adverse-events/run-sync-get-dataset-items?token=<YOUR_API_TOKEN>' \
  -H 'Content-Type: application/json' \
  -d '{"dataset": "drug-recalls", "keyword": "insulin", "maxItems": 20}'
```

### FAQ

**Which datasets?**

Drug, device and food recalls; drug (FAERS), device (MAUDE) and food (CAERS) adverse events.

**Data source?**

openFDA public API.

**Something not working?**

Open an issue on the Actor's Issues tab, and it will be fixed quickly.

### More details

Pull FDA drug, device and food recalls (enforcement reports) and adverse event reports (FAERS, MAUDE, CAERS) from the official openFDA API with simple filters.

One Actor for the most-used **openFDA** datasets: **recall enforcement reports** (drug, device, food), **device recall details**, and **adverse event reports** (FAERS drugs, MAUDE devices, CAERS food/cosmetics). Filter by product/firm keyword, recall class and date, or pass any raw openFDA query.

**Uses:** pharmacovigilance and safety signal monitoring, supplier and recall monitoring for retailers/hospitals, regulatory and competitive intelligence, research datasets. Schedule it for daily recall alerts.

##### Output

Each record carries the openFDA fields (recall number, class, firm, product, reason, dates, status, distribution; or the event report details), plus `endpoint` and `source`.

##### Source and terms

Data comes from the public openFDA API (`api.fda.gov`) under openFDA's terms. FDA notes this data is unvalidated, so do not use it for clinical decisions. FDA does not endorse this Actor. Add your own free API key for heavy use.

##### Pricing

Pay per event: **record**. Charged per openFDA record returned. You pay only for results. Not-found/error rows are free. Apify platform usage is included.

##### Example input

```json
{
  "dataset": "drug-recalls",
  "keyword": "insulin",
  "maxItems": 3
}
```

Built by clearpathdata, a maker of official-government-data Actors. Questions and feature requests are welcome in the Issues tab.

# Actor input Schema

## `dataset` (type: `string`):

Which openFDA dataset.

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

Product, brand, generic or company name.

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

Enforcement datasets only.

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

Report/received date from.

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

Report/received date to.

## `search` (type: `string`):

Optional raw openFDA search expression, ANDed with the filters.

## `apiKey` (type: `string`):

Free key from open.fda.gov for higher rate limits.

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

openFDA allows paging to 26,000 records per query.

## Actor input object example

```json
{
  "dataset": "drug-recalls",
  "keyword": "insulin",
  "maxItems": 20
}
```

# 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 = {
    "keyword": "insulin",
    "maxItems": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("clearpathdata/openfda-recalls-adverse-events").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 = {
    "keyword": "insulin",
    "maxItems": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("clearpathdata/openfda-recalls-adverse-events").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 '{
  "keyword": "insulin",
  "maxItems": 20
}' |
apify call clearpathdata/openfda-recalls-adverse-events --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,clearpathdata/openfda-recalls-adverse-events"
        }
    }
}
```

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/YUr0wWU2tadAFj7uz/builds/TxSEMIzOmp3OFs8PZ/openapi.json