openFDA API: FDA Recalls, Drug Labels & Device Reports

Pull four kinds of FDA record straight from the official openFDA API (api.fda.gov) as flat, ready-to-use rows: recall enforcement reports for drugs, medical devices and food; structured product labels (SPL) for any brand or generic drug name; medical device adverse event reports from MAUDE; and the export status of every openFDA dataset. Every row carries the same handful of shared columns (recordId, title, organization, category, date, url), every date is UTC ISO-8601, and every report links back to the exact openFDA record it came from. No API key, no proxy, no browser.

The data is US public-domain FDA data. It is not medical advice: a recall or an adverse event record is a report, not proof that a product caused harm, and the datasets can be incomplete or several weeks behind.

Use cases

• Pharmacovigilance and pharmacy compliance: a standing list of Class I drug recalls of the last 12 months, with the reason, the recalling firm and the distribution pattern, to check against your own stock lists.
• Food safety and retail QA: every food recall whose stated reason mentions an undeclared allergen or ingredient, so a grocery or private-label buyer can react the same week the recall is published.
• Hospital biomedical engineering and device distributors: the running list of device recall enforcement reports, filtered to a device family or a manufacturer, to match against installed equipment.
• Clinical and pharmacy app developers: the newest SPL label per generic name (set id, version, NDC codes, route, labeler, application number), which answers "which label do I show for this drug" without parsing SPL XML.
• Device safety, quality and product-liability research: MAUDE reports for one device type or product code, with device and patient problem codes and a detail link that actually opens the report on the FDA site.
• Data engineering: mode: "datasets" answers "how fresh is FDA data right now" — export date and record count for each of the 30 openFDA datasets — before a pipeline run trusts them.
• Monitoring: sinceDays plus onlyNew turns any of the above into a scheduled watchlist that emits only records it has not delivered before.

Input

Nothing is required. The defaults run a drug-recall search; query is the only field with a prefilled example.

Field	Type	Default	Allowed values / notes
mode	string	recalls	recalls, drugLabels, deviceEvents, datasets — see Modes
productArea	string	drug	drug, device, food. Which enforcement dataset recalls reads; ignored by other modes
query	string	(prefill insulin)	Search words. Several words are searched as a phrase. Empty = everything matching the filters
searchField	string	auto	Which field query is matched in — see Search fields
classifications	string[]	all	Class I, Class II, Class III. recalls only — see Recall classes
recallStatuses	string[]	all	Ongoing, Completed, Terminated, Pending. recalls only
eventTypes	string[]	all	Death, Injury, Malfunction, Other, No answer provided. deviceEvents only
productCode	string	—	Three-character FDA device product code, e.g. QFG. deviceEvents only — see Device product codes
state	string	—	Two-letter US state of the recalling firm, e.g. NJ. recalls only
country	string	—	Country of the recalling firm as FDA spells it, e.g. United States. recalls only
sinceDays	integer	—	1–3650. Keep only records whose main date falls in the last N days (UTC). Wins over fromDate/toDate
fromDate	string	—	Earliest date, YYYY-MM-DD, inclusive
toDate	string	—	Latest date, YYYY-MM-DD, inclusive
onlyNew	boolean	false	Emit only records this input has not delivered in an earlier run
sortOrder	string	newest	newest or oldest, by the mode's main date
maxItems	integer	25	1–5000 rows
includeText	boolean	false	Add SPL section text (drugLabels) or the report narrative (deviceEvents)
labelSections	string[]	purpose, indications and usage, warnings	Which SPL sections includeText adds — see Label sections
fields	string[]	all	Keep only these output fields, in this order
customSearch	string	—	A raw openFDA expression ANDed to everything above — see Raw search expressions

Choice fields accept only the listed values (Apify rejects anything else before the run starts). Free-text fields are normalised — query is trimmed, state and productCode are upper-cased — and an impossible combination (e.g. productCode with mode: "recalls") fails the run with a clear message instead of quietly returning something wider.

Reference

Modes

mode	openFDA endpoint	What one row is	Filters that apply
recalls	/{drug|device|food}/enforcement.json	One recall enforcement report	query, searchField, classifications, recallStatuses, state, country, dates
drugLabels	/drug/label.json	One SPL label version	query, searchField, dates (effective_time), includeText, labelSections
deviceEvents	/device/event.json	One MAUDE adverse event report	query, searchField, eventTypes, productCode, dates, includeText
datasets	/download.json	One openFDA dataset (30 of them)	none — the date and search filters are ignored and reported as such

The main date differs per mode: report_date for recalls, effective_time for labels, date_received for device reports. sinceDays, fromDate, toDate and sortOrder all work on that field.

Recall classes

Value	What FDA means by it
Class I	Reasonable probability that the product causes serious harm or death
Class II	May cause temporary or medically reversible harm; serious harm unlikely
Class III	Unlikely to cause harm, but the product violates FDA regulations

Recall statuses are Ongoing (the firm is still recalling), Completed, Terminated (FDA closed the recall) and Pending (not yet classified).

Search fields

searchField picks the field query is matched in. A field an endpoint does not have falls back to auto, with a warning in the log — the search is never silently widened.

searchField	recalls	drugLabels	deviceEvents
auto	every field of the record	every field	every field
product	product_description	package label text	device.generic_name
reason	reason_for_recall	→ auto	→ auto
firm	recalling_firm	→ auto	manufacturer_name
brandName	openfda.brand_name	openfda.brand_name	device.brand_name
genericName	openfda.generic_name	openfda.generic_name	device.generic_name
manufacturer	openfda.manufacturer_name	openfda.manufacturer_name	device.manufacturer_d_name
productCode	not possible (see below)	→ auto	device.device_report_product_code
identifier	recall_number	set_id, SPL id or NDC	MAUDE report number or report key

identifier looks up one exact record. When the id does not exist, the run writes a single row with found: false instead of returning nothing.

Device recall records carry no product code — measured on 2026-09-19, 0 of 39,949 device enforcement records have one and there is no field to fall back to. productCode (or searchField: "productCode") combined with mode: "recalls" therefore fails with a message instead of returning an unfiltered list. Search device recalls by product description or recalling firm instead.

Device product codes

A product code is FDA's three-letter key for a device type. Examples verified in the device classification data:

Code	Device type	Class
QFG	Alternate controller enabled insulin infusion pump	2
QJY	Infusion pump, drug specific, pharmacy-filled	2
DTE	Pulse generator, pacemaker, external	2
DXY	Implantable pacemaker pulse generator	3
PQF	Sensor, glucose, invasive, non-adjunctive	3
DQO	Catheter, intravascular, diagnostic	2
QOS	Continuous ventilator	—
JDG	Prosthesis, hip, femoral component, cemented, metal	2

To find the code for any other device, search FDA's classification list by name in a browser: https://api.fda.gov/device/classification.json?search=device_name:"insulin pump"&limit=10. Each device event row also carries the code that FDA filed it under, so one broad genericName run tells you which code to narrow to.

Label sections

includeText adds a sections object to drug label rows. labelSections picks which ones: purpose, indicationsAndUsage, dosageAndAdministration, warnings, adverseReactions, contraindications, activeIngredient, inactiveIngredient, description, howSupplied. Sections a particular label does not have are left out. These fields can be tens of kilobytes each, which is why they are off by default.

Raw search expressions

customSearch is ANDed to everything the input already built, for people who know the openFDA field names. Useful starting points:

• drug labels: openfda.pharm_class_epc:"Nonsteroidal Anti-inflammatory Drug [EPC]", openfda.route:"ORAL", openfda.is_original_packager:true
• enforcement: voluntary_mandated:"Voluntary: Firm initiated", distribution_pattern:"Nationwide"
• device events: patient.patient_problems:"Death", device.device_class:3, source_type:"Consumer"

Multi-word values must be quoted. An expression openFDA cannot parse fails the run with the API's own message, naming customSearch as the culprit.

Examples

Class I drug recalls of the last 12 months — pharmacovigilance and pharmacy compliance.

{ "mode": "recalls", "productArea": "drug", "classifications": ["Class I"], "sinceDays": 365, "sortOrder": "newest", "maxItems": 20 }

Food recalls for undeclared allergens — food safety and retail QA.

{ "mode": "recalls", "productArea": "food", "query": "undeclared", "searchField": "reason", "sinceDays": 180, "maxItems": 20 }

Device recalls of the last 6 months from one firm — hospital biomedical engineering.

{ "mode": "recalls", "productArea": "device", "query": "Medtronic", "searchField": "firm", "sinceDays": 180, "maxItems": 25 }

Newest drug labels for a generic name — clinical and pharmacy apps.

{ "mode": "drugLabels", "query": "ibuprofen", "searchField": "genericName", "sortOrder": "newest", "maxItems": 15 }

Adverse event reports for one device family — device safety and liability research.

{ "mode": "deviceEvents", "query": "infusion pump", "searchField": "genericName", "sinceDays": 180, "maxItems": 20 }

Device reports with a death outcome, as a daily watchlist — safety monitoring.

{ "mode": "deviceEvents", "eventTypes": ["Death"], "sinceDays": 180, "onlyNew": true, "maxItems": 15 }

How fresh is each FDA dataset — data engineering.

{ "mode": "datasets", "maxItems": 40 }

Output

One real row from a cloud run with the default input (mode: "recalls", productArea: "drug", query: "insulin"), with the long codeInfo trimmed:

{
  "mode": "recalls",
  "recordId": "D-0806-2026",
  "title": "MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.",
  "organization": "Baxter Healthcare Corporation",
  "category": "Class II",
  "date": "2026-09-09",
  "status": "Ongoing",
  "found": true,
  "recallNumber": "D-0806-2026",
  "eventId": "99500",
  "productArea": "drug",
  "classification": "Class II",
  "recallStatus": "Ongoing",
  "productType": "Drugs",
  "productDescription": "MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.",
  "reasonForRecall": "CGMP Deviations",
  "productQuantity": null,
  "codeInfo": "Lot # NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, Exp Date: 12/31/2027; Lot # NC193719, NC193849, …",
  "moreCodeInfo": null,
  "distributionPattern": "US Nationwide; Puerto Rico; and Chile.",
  "recallingFirm": "Baxter Healthcare Corporation",
  "firmAddress": "1 Baxter Pkwy",
  "firmCity": "Deerfield",
  "firmState": "IL",
  "firmPostalCode": "60015-4625",
  "firmCountry": "United States",
  "voluntaryMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "Letter",
  "recallInitiationDate": "2026-08-06",
  "centerClassificationDate": "2026-08-28",
  "reportDate": "2026-09-09",
  "brandNames": [
    "MYXREDLIN"
  ],
  "genericNames": [
    "INSULIN HUMAN"
  ],
  "manufacturerNames": [
    "Baxter Healthcare Corporation"
  ],
  "productNdcs": [
    "0338-0126"
  ],
  "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0806-2026%22&limit=1",
  "detailUrl": null,
  "fetchedAt": "2026-09-19T20:14:59.688Z"
}

Shared fields, present in every mode:

Field	Type	Meaning
mode	string	Which job produced the row
recordId	string	Recall number, SPL set id, MAUDE report number or dataset key
title	string	Product description, brand (generic) name, device brand or dataset name
organization	string	Recalling firm, labeler or device manufacturer
category	string	Recall class, product type, event type or dataset category
date	string	The mode's main date, YYYY-MM-DD UTC
status	string	Recall status or MAUDE report type; empty for labels and datasets
found	boolean	false only for an identifier lookup that matched nothing
url	string	openFDA URL that returns exactly this record
detailUrl	string	FDA or label page for the record, where one exists
fetchedAt	string	Fetch time, ISO 8601 UTC

recalls adds: recallNumber, eventId, productArea, classification, recallStatus, productType, productDescription, reasonForRecall, productQuantity, codeInfo, moreCodeInfo, distributionPattern, recallingFirm, firmAddress, firmCity, firmState, firmPostalCode, firmCountry, voluntaryMandated, initialFirmNotification, recallInitiationDate, centerClassificationDate, reportDate, brandNames[], genericNames[], manufacturerNames[], productNdcs[].

drugLabels adds: setId, splId, version, effectiveDate, brandName, brandNames[], genericName, genericNames[], manufacturerName, substanceNames[], productNdcs[], packageNdcs[], routes[], productType, rxcuis[], pharmClasses[], applicationNumbers[], isOriginalPackager, labelUrl, and sections{} with includeText. The scalar brandName/genericName are the first entry of the matching array, so filters and spreadsheets work on a string.

deviceEvents adds: reportNumber, mdrReportKey, eventType, dateReceived, dateOfEvent, dateReport, sourceType, deviceBrandName, deviceGenericName, deviceManufacturer, productCode, modelNumber, catalogNumber, lotNumber, udiDi, deviceName, deviceClass, medicalSpecialty, regulationNumber, productProblems[], patientProblems[], deviceCount, patientCount, remedialAction, summaryReportFlag, and narrative with includeText.

datasets adds: datasetKey, endpointCategory, endpointName, exportDate, totalRecords, partitionCount, downloadSizeMb, downloadUrl.

Link fields: url is always an api.fda.gov query that returns this single record. For device reports detailUrl is the MAUDE detail page built from mdr_report_key plus the product code — building it from the report number instead is the usual reason such links do not open. For drug labels detailUrl and labelUrl point at the DailyMed page of the SPL set; for datasets detailUrl is the openFDA documentation page. Recall enforcement records have no per-record page on the FDA site, so detailUrl is empty there.

Dataset views: Overview (works for every mode), Recall enforcement reports, Drug labels (SPL), Device adverse events.

A SUMMARY record in the run's key-value store holds the endpoint and the exact search expression that was sent, the dataset's last_updated date, the total number of matches, rows written, API requests used, how many rows were dropped by a filter or as already seen, every input warning, and the FDA disclaimer.

Use it from code / agents

curl -X POST "https://api.apify.com/v2/acts/yadroo~openfda-records/run-sync-get-dataset-items?token=$APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"mode":"recalls","productArea":"drug","classifications":["Class I"],"sinceDays":365,"maxItems":20}'

import { ApifyClient } from 'apify-client';
const client = new ApifyClient({ token: process.env.APIFY_TOKEN });
const run = await client.actor('yadroo/openfda-records').call({
    mode: 'deviceEvents', query: 'infusion pump', searchField: 'genericName', sinceDays: 180, maxItems: 20,
});
const { items } = await client.dataset(run.defaultDatasetId).listItems();

from apify_client import ApifyClient
client = ApifyClient(os.environ["APIFY_TOKEN"])
run = client.actor("yadroo/openfda-records").call(run_input={
    "mode": "drugLabels", "query": "ibuprofen", "searchField": "genericName", "maxItems": 15,
})
items = client.dataset(run["defaultDatasetId"]).list_items().items

For LLM agents, fields keeps rows small enough to paste into a prompt: {"mode":"recalls","classifications":["Class I"],"sinceDays":90,"fields":["recallNumber","productDescription","reasonForRecall","recallingFirm","reportDate"]}.

MCP: add https://mcp.apify.com to Claude / Cursor / any MCP client and call the yadroo/openfda-records tool with the same JSON input.

Pricing

Pay per event: $0.001 per run start + $0.002 per dataset row. Nothing else is charged; there is no proxy and no browser in the run.

Run	Cost
The default 25-row recall search	$0.051
50 rows (a typical monitoring run, ~40 s)	$0.101
500 rows	$1.001

Lower tiers on Apify reduce the per-row price automatically (Bronze −10 %, Silver −20 %, Gold and above −30 %).

Limits & FAQ

• Rate limit. The actor uses openFDA without an API key: 240 requests per minute and 1,000 per day per IP. A run needs one request per 1,000 recall rows (500 for labels and device reports) plus a retry budget, so a normal run costs 1–2 requests. 429 answers are retried with backoff.
• Paging depth. openFDA refuses to page past 25,000 records of one query. maxItems is capped at 5,000, which stays well inside that, but a query that would need to skip further stops with a message asking you to narrow the filters.
• Freshness. FDA publishes in batches, roughly weekly. On 2026-09-19 the enforcement datasets were last updated 2026-09-09 and device events 2026-09-08, with the newest report received 2026-08-31. A sinceDays window shorter than about 30 days can legitimately return nothing — that is the source, not the actor.
• Empty results are not errors. openFDA answers "no matches" with HTTP 404; the actor reports zero rows with a message that says what to widen. Only an identifier lookup writes a row (found: false), so you can tell "id does not exist" from "run failed".
• openfda is often empty. Device and food recall records usually have no openfda block, so brandNames, genericNames and productNdcs are empty arrays on those rows. Drug recalls and labels do have it.
• Recall numbers can be missing. Food enforcement records are published before FDA assigns a recall number; those rows fall back to event-<eventId> as recordId and leave recallNumber empty.
• No personal data. MAUDE records contain patient age, sex, weight, race and ethnicity and a manufacturer contact person with phone and address. None of those are ever written to the dataset. Patient problem codes and the device and patient counts are kept, because that is what safety analysis needs. Company names and addresses in recall records stay — they are the subject of the record.
• What is not here. This actor covers four endpoints. openFDA has more (drug adverse events/FAERS, NDC directory, 510(k), UDI, Drugs@FDA, Orange Book, drug shortages, food and cosmetic events, tobacco reports); mode: "datasets" lists them all with their freshness, but reading their records is not implemented. FDA guidance documents are not part of openFDA at all.
• Is this medical advice? No. openFDA data is provided as-is. Adverse event and recall records are reports and do not establish that a product caused a problem. Do not use this data to make decisions about medical care.
• Licence. FDA data is US public domain and may be used commercially; FDA asks for credit and does not endorse any product built on it. The actor calls only api.fda.gov.

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