# openFDA Enforcement (Recall) Monitor (`bytehavenstudios/openfda-enforcement-monitor`) Actor Monitor FDA recall (enforcement) reports across drug, device and food. One normalized record per recall (number, Class I/II/III, status, firm, product, reason, dates), with type/class filters, a new-since-last-run mode, and change-detection flagging classification escalations. openFDA, CC0. - **URL**: https://apify.com/bytehavenstudios/openfda-enforcement-monitor.md - **Developed by:** [ByteHaven Studios](https://apify.com/bytehavenstudios) (community) - **Categories:** Developer tools, News - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $10.00 / 1,000 recall returneds 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/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use 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 ## openFDA Enforcement (Recall) Monitor Monitor **FDA recall (enforcement) reports** across **drug, device and food** categories in a single run. Give it categories, classifications and/or a date window; it returns one normalized record per recall, with a **new-since-last-run** mode and **change-detection** that flags **classification escalations** (Class III→II→I) and **termination events**. Clean REST/JSON — no browser, no proxy, no login, no API key required (an optional free key raises rate limits). **Data source: FDA openFDA (U.S. public domain, CC0 1.0).** > **Status: scaffold (v0.1, in progress).** This Actor is being built in slices; the runtime logic > (`src/openfda.js`, `src/filters.js`, `src/main.js`) is landing incrementally. This README documents > the intended product surface. See `CHANGELOG.md` for what's implemented so far. --- ### What it does For each run it queries the openFDA **enforcement** endpoints — `/drug/enforcement.json`, `/device/enforcement.json`, `/food/enforcement.json` — for the categories you select, filtered by a `report_date` window, normalizes all three schemas into one record shape, applies your filters, dedupes on `recall_number`, and pushes one dataset item per recall. - **Recent recalls** (default): recalls whose `report_date` is on/after `reportedSince` (or a recent trailing window if unset), across every selected category in one pass. - **Cross-category edge**: watching drug **and** device **and** food recalls together — normalized to one schema — is the moat. Incumbents grab the glamorous drug-label / adverse-event endpoints and leave the boring, weekly-lagged enforcement feeds un-normalized and un-joined. - **New-recall monitor**: `monitorNewOnly` persists the set of already-reported `recall_number`s (in the Actor's key-value store) and, on the next scheduled run, returns only recalls not seen before. - **Change-detection**: `detectChanges` persists each recall's prior `classification` and `status` and, on later runs, flags recalls that **escalated** (Class III→II→I) or whose status changed (e.g. `On-Going`→`Terminated`). Change-detection over a weekly-refreshed corpus nobody else timestamps for first-seen. - **Filters**: by `recallCategories` (drug / device / food), `classifications` (Class I / II / III), and `statuses`. ### Inputs | Input | Type | Notes | |---|---|---| | `recallCategories` | string[] | `drug`, `device`, `food`. Empty = all three | | `classifications` | string[] | `Class I`, `Class II`, `Class III`. Empty = all classes | | `statuses` | string[] | e.g. `On-Going`, `Completed`, `Terminated`. Empty = all statuses | | `reportedSince` | string | `YYYY-MM-DD` — report_date on/after. Empty = recent trailing window | | `monitorNewOnly` | boolean | Return only `recall_number`s not seen in a previous run | | `detectChanges` | boolean | Flag classification escalations + status changes vs stored prior state (default on) | | `fields` | string[] | Override the kept output fields (empty = sensible default set) | | `maxResults` | integer | Cap total recalls returned (0 = no cap) | | `apiKey` | string | Optional openFDA api_key (raises daily rate limit; not required) | | `proxyConfiguration` | object | Optional; the API is open and needs no proxy. Default: none | ### Output — one record per recall ```json { "recall_number": "D-1234-2026", "category": "drug", "status": "Ongoing", "classification": "Class II", "product_type": "Drugs", "product_description": "Atorvastatin Calcium Tablets, 40 mg, 90-count bottle", "reason_for_recall": "Failed dissolution specifications at the 12-month stability time point.", "recalling_firm": "Example Pharma Inc.", "city": "Trenton", "state": "NJ", "country": "United States", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "event_id": "90210", "recall_initiation_date": "2026-06-15", "center_classification_date": "2026-07-01", "report_date": "2026-07-08", "termination_date": null, "isNew": true, "change": null, "fetchedAt": "2026-07-10T14:00:00.000Z" } ```` `category` marks which endpoint the recall came from (`drug` / `device` / `food`). Date fields are the API's `YYYYMMDD` strings parsed best-effort to `YYYY-MM-DD` (null when absent). `isNew` is `true` when a `recall_number` was not seen in a previous run (only meaningful with `monitorNewOnly`). `change` is an object when `detectChanges` is on and the recall's classification escalated or status changed since a prior run — e.g. `{ "type": "classification-escalation", "from": "Class III", "to": "Class II" }` or `{ "type": "status-change", "from": "Ongoing", "to": "Terminated" }` — otherwise `null`. #### Control records (not charged) Two non-recall records may be pushed to signal run state. Neither triggers a `recall-returned` charge: | Record | When | Shape | |---|---|---| | `_noData` | The API returned no recalls for the requested filters/window | `{ "_noData": true, "filters": {...}, "message": "...", "fetchedAt": "..." }` | | `_error` | The fetch failed after retries, or normalization threw | `{ "_error": true, "filters": {...}, "message": "...", "fetchedAt": "..." }` | `_noData` keeps a zero-result run green and auditable rather than pushing a silent empty dataset. ### Pricing (pay-per-event) One **`recall-returned`** event is charged per record pushed to the dataset. Cost scales with results, not runtime. Use `recallCategories` / `classifications` / `statuses` / `maxResults` / `monitorNewOnly` to keep spend proportional to signal. (Live price shown on the Store page; see `docs/PRICING.md`.) ### Data source & attribution openFDA content and data are **public domain under a Creative Commons CC0 1.0 Universal dedication** — free to copy, modify and redistribute, including commercially, without asking permission. No key and no attribution are required; we credit the FDA / openFDA as a courtesy. Full compliance record: [`COMPLIANCE.md`](./COMPLIANCE.md). > openFDA is a research/informational service; recall data may be incomplete or lag the FDA's own > systems and is **not** a substitute for the official recall notices. This Actor relays the data as > published; it does not certify accuracy. ### Maintenance notes - **Three schemas drift independently** — drug / device / food enforcement records carry overlapping-but-not-identical fields; the normalizer is defensive and the kept-field set is documented. - **`YYYYMMDD` string dates** — parsed best-effort to `YYYY-MM-DD`; the raw values are folded into the normalized fields, absent dates become null. - **Weekly refresh** — enforcement data updates weekly, so a monitoring schedule should overlap its `report_date` window run-to-run to avoid missing a late-posted recall. - **Change churn** — recalls get re-classified and terminated over time; `detectChanges` is what turns that churn into events. The `openfda{}` enrichment block is intermittently absent and is not relied on. - **Rate limits** — keyless access is 240 req/min and 1000/day per IP; large historical pulls should narrow by category/date or supply an `apiKey` rather than paging past the cap. # Actor input Schema ## `recallCategories` (type: `array`): Which openFDA enforcement endpoints to query. drug = /drug/enforcement.json, device = /device/enforcement.json, food = /food/enforcement.json. Empty = all three (the cross-category moat). ## `classifications` (type: `array`): Restrict to these FDA recall classifications. Class I = most serious (reasonable probability of serious harm/death), Class II = temporary/reversible harm, Class III = unlikely to cause harm. Empty = all classes. ## `statuses` (type: `array`): Restrict to these recall statuses (openFDA `status` field). Typical values: On-Going, Completed, Terminated, Pending. Empty = all statuses. ## `reportedSince` (type: `string`): Only return recalls whose report\_date is on/after this date (maps to search=report\_date:\[YYYYMMDD+TO+today]). Leave empty to default to a recent trailing window. Ignored if 'Only new since last run' is on (the stored watermark drives the window instead). ## `monitorNewOnly` (type: `boolean`): Persist the set of recall\_numbers already reported (in the Actor's key-value store) and, on the next run, return only recalls not seen before. Turns this Actor into a new-recall monitor across scheduled runs. ## `detectChanges` (type: `boolean`): Persist each recall's prior classification and status (in the Actor's key-value store) and, on later runs, flag recalls whose classification escalated (Class III→II→I) or whose status changed (e.g. On-Going→Terminated). Changed records carry a `change` object. This is the change-detection edge over a weekly-refreshed corpus. ## `fields` (type: `array`): Optional. Override the set of recall fields kept on each output record. Empty = a sensible default set (see README). Example extras: code\_info, distribution\_pattern, product\_quantity, more\_code\_info. ## `maxResults` (type: `integer`): Cap the total number of recalls returned (across all selected categories). 0 = no cap (paginate to the API's limit). ## `apiKey` (type: `string`): Optional free openFDA api\_key. Keyless access allows 240 requests/min and 1000/day per IP; a key raises the daily limit to 120,000. Not required for typical scheduled runs. Get one at https://open.fda.gov/apis/authentication/. ## `proxyConfiguration` (type: `object`): Optional. The openFDA API is a clean, open, public endpoint and needs NO proxy. You may enable Apify Proxy only to distribute requests if you run very large historical pulls. Default: no proxy. ## Actor input object example ```json { "recallCategories": [ "drug", "device", "food" ], "classifications": [], "statuses": [], "reportedSince": "2026-01-01", "monitorNewOnly": false, "detectChanges": true, "fields": [], "maxResults": 0, "proxyConfiguration": { "useApifyProxy": false } } ``` # Actor output Schema ## `recalls` (type: `string`): One FDA enforcement (recall) report for a drug, device or food product. Rendered as the Recalls table (see the dataset schema). # 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 '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "recallCategories": [ "drug", "device", "food" ], "classifications": [], "statuses": [], "fields": [] }; // Run the Actor and wait for it to finish const run = await client.actor("bytehavenstudios/openfda-enforcement-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 '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "recallCategories": [ "drug", "device", "food", ], "classifications": [], "statuses": [], "fields": [], } # Run the Actor and wait for it to finish run = client.actor("bytehavenstudios/openfda-enforcement-monitor").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "recallCategories": [ "drug", "device", "food" ], "classifications": [], "statuses": [], "fields": [] }' | apify call bytehavenstudios/openfda-enforcement-monitor --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=bytehavenstudios/openfda-enforcement-monitor", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "openFDA Enforcement (Recall) Monitor", "description": "Monitor FDA recall (enforcement) reports across drug, device and food. One normalized record per recall (number, Class I/II/III, status, firm, product, reason, dates), with type/class filters, a new-since-last-run mode, and change-detection flagging classification escalations. openFDA, CC0.", "version": "0.1", "x-build-id": "97sh4izuTSFDXuqcb" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/bytehavenstudios~openfda-enforcement-monitor/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-bytehavenstudios-openfda-enforcement-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/bytehavenstudios~openfda-enforcement-monitor/runs": { "post": { "operationId": "runs-sync-bytehavenstudios-openfda-enforcement-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/bytehavenstudios~openfda-enforcement-monitor/run-sync": { "post": { "operationId": "run-sync-bytehavenstudios-openfda-enforcement-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "properties": { "recallCategories": { "title": "Recall categories", "type": "array", "description": "Which openFDA enforcement endpoints to query. drug = /drug/enforcement.json, device = /device/enforcement.json, food = /food/enforcement.json. Empty = all three (the cross-category moat).", "items": { "type": "string", "enum": [ "drug", "device", "food" ], "enumTitles": [ "Drug recalls", "Device recalls", "Food recalls" ] } }, "classifications": { "title": "Classifications", "type": "array", "description": "Restrict to these FDA recall classifications. Class I = most serious (reasonable probability of serious harm/death), Class II = temporary/reversible harm, Class III = unlikely to cause harm. Empty = all classes.", "items": { "type": "string", "enum": [ "Class I", "Class II", "Class III" ], "enumTitles": [ "Class I (most serious)", "Class II", "Class III (least serious)" ] } }, "statuses": { "title": "Recall statuses", "type": "array", "description": "Restrict to these recall statuses (openFDA `status` field). Typical values: On-Going, Completed, Terminated, Pending. Empty = all statuses.", "items": { "type": "string" } }, "reportedSince": { "title": "Reported on/after (YYYY-MM-DD)", "type": "string", "description": "Only return recalls whose report_date is on/after this date (maps to search=report_date:[YYYYMMDD+TO+today]). Leave empty to default to a recent trailing window. Ignored if 'Only new since last run' is on (the stored watermark drives the window instead)." }, "monitorNewOnly": { "title": "Only new since last run", "type": "boolean", "description": "Persist the set of recall_numbers already reported (in the Actor's key-value store) and, on the next run, return only recalls not seen before. Turns this Actor into a new-recall monitor across scheduled runs.", "default": false }, "detectChanges": { "title": "Detect classification / status changes", "type": "boolean", "description": "Persist each recall's prior classification and status (in the Actor's key-value store) and, on later runs, flag recalls whose classification escalated (Class III→II→I) or whose status changed (e.g. On-Going→Terminated). Changed records carry a `change` object. This is the change-detection edge over a weekly-refreshed corpus.", "default": true }, "fields": { "title": "Fields to keep", "type": "array", "description": "Optional. Override the set of recall fields kept on each output record. Empty = a sensible default set (see README). Example extras: code_info, distribution_pattern, product_quantity, more_code_info.", "items": { "type": "string" } }, "maxResults": { "title": "Max recalls per run", "minimum": 0, "type": "integer", "description": "Cap the total number of recalls returned (across all selected categories). 0 = no cap (paginate to the API's limit).", "default": 0 }, "apiKey": { "title": "openFDA API key (optional)", "type": "string", "description": "Optional free openFDA api_key. Keyless access allows 240 requests/min and 1000/day per IP; a key raises the daily limit to 120,000. Not required for typical scheduled runs. Get one at https://open.fda.gov/apis/authentication/." }, "proxyConfiguration": { "title": "Proxy configuration", "type": "object", "description": "Optional. The openFDA API is a clean, open, public endpoint and needs NO proxy. You may enable Apify Proxy only to distribute requests if you run very large historical pulls. Default: no proxy.", "default": { "useApifyProxy": false } } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```