openFDA Scraper

FDA recalls, adverse-event reports, drug labels, drug approvals and 510(k) clearances from openFDA, searchable by keyword and date, as clean JSON.

openFDA is the US Food and Drug Administration's public data service: millions of records on the drugs, medical devices and foods sold in the United States. This Actor turns it into a dataset. Pick one of nine FDA datasets, type search terms such as a drug, device, firm or ingredient, add a date range or an openFDA query, and get one row per record, newest first: drug, device and food recalls with their class, status, reason, firm and distribution; drug adverse-event reports (FAERS) with seriousness, patient age and sex, the drugs involved and each reaction's outcome; medical-device reports (MAUDE) with the devices, problems and event narrative; food, supplement and cosmetic adverse-event reports (CAERS); drug labels with the boxed warning, indications, dosage, contraindications, warnings, adverse reactions and interactions; Drugs@FDA applications with their products, approval date and every submission with its letters and labels; and 510(k) device clearances with their decision. Every row keeps the full FDA record too. No login and no proxy; an API key is optional. Built for pharmacovigilance and drug-safety teams, regulatory affairs and quality, medical-device and food-safety compliance, competitive intelligence on products and manufacturers, healthcare analysts, journalists and researchers.

⚡ Quick start

{
  "dataset": "drug/enforcement",
  "searchTerms": ["metformin"],
  "maxItems": 5
}

Or every serious Ozempic adverse-event report received in 2025:

{
  "dataset": "drug/event",
  "searchTerms": ["ozempic"],
  "searchQuery": "serious:1",
  "dateFrom": "2025-01-01",
  "dateTo": "2025-12-31",
  "maxItems": 1000
}

🧩 Input

Field	Type	Required	Default	Description
dataset	string	no	"drug/enforcement"	The FDA dataset to search (see the table below).
searchTerms	array	no	—	Words to look for, one search per line, such as metformin or insulin pump. Each is matched as a phrase in the dataset's main text (see the table below).
searchQuery	string	no	—	Optional openFDA query syntax, combined with every search term, such as classification:"Class I" AND state:CA. Without search terms it runs as a search of its own.
dateFrom	string	no	—	Only records on or after this date (YYYY-MM-DD), on the dataset's main date.
dateTo	string	no	—	Only records on or before this date (YYYY-MM-DD), on the dataset's main date.
maxItems	integer	no	—	Maximum number of records per search term, query or start URL, newest first. The input form starts at 5; leave it empty to get every match.
startUrls	array	no	—	Public FDA pages to look up: a device recall, 510(k), MAUDE report or Drugs@FDA application on accessdata.fda.gov, or a DailyMed label or search page. Each record page returns that one record.
apiKey	string	no	—	Optional free openFDA API key. Raises openFDA's daily limit from 1,000 to 120,000 requests.
proxyConfiguration	object	no	{ "useApifyProxy": false }	Proxy settings. openFDA needs no proxy.

With no search terms, query or start URL, the Actor returns the newest records of the whole dataset, narrowed by the date range if you set one.

Datasets. Each search term is matched as a phrase in the fields listed here, and the date range applies to the date shown:

dataset	Records	Search terms match	Dates filter on
drug/enforcement	Drug recalls (FDA enforcement reports)	Product description, reason for recall, recalling firm	Report date
drug/event	Drug adverse-event reports (FAERS)	Drug name, brand and generic names, reaction terms	Date FDA received it
drug/label	Drug labels (structured product labels)	Brand, generic and substance names, manufacturer, indications	Effective date
drug/drugsfda	Drug approvals (Drugs@FDA applications)	Brand names, active ingredients, sponsor	Submission date
device/event	Medical-device adverse-event reports (MAUDE)	Device brand and generic names, manufacturer	Date FDA received it
device/recall	Medical-device recalls	Product description, reason for recall, firm, device name	Date posted
device/510k	510(k) premarket clearances	Device name, applicant	Decision date
food/enforcement	Food recalls (FDA enforcement reports)	Product description, reason for recall, recalling firm	Report date
food/event	Food, dietary supplement and cosmetic adverse events (CAERS)	Product name, industry, reaction terms	Date created

openFDA queries. searchQuery takes openFDA's own syntax, field by field, so any field of a record can be filtered, for example classification:"Class I" and status:Ongoing for recalls, patient.patientsex:2 or occurcountry:US for drug reports, openfda.product_type:"HUMAN OTC DRUG" for labels, or decision_code:SESE for 510(k)s. Join conditions with AND, OR and NOT.

📤 Output

Each FDA record is one dataset row. Every row has dataset, id, url, title, date and raw; the other fields depend on the dataset, as listed below. Fields a record does not have are null (or an empty list), and raw always holds the complete FDA record with every field.

Fields

Field	Type	Description
dataset	string	The dataset the record comes from, such as drug/enforcement.
id	string	The record's FDA identifier: recall number, report ID, label set ID, application number or K number.
url	string	The record's public FDA page (device recall, MAUDE report, DailyMed label, Drugs@FDA or 510(k) page), or the dataset's openFDA page when FDA has none per record.
title	string	A short label: the product, drug or device and, for reports, what happened.
date	string	The record's main date (the one dateFrom and dateTo filter on), YYYY-MM-DD.
raw	object	The full openFDA record, unchanged.
recallNumber	string	Recalls: FDA recall number, such as D-0657-2026.
eventId	string	Recalls: the recall event the product belongs to.
status	string	Recalls: Ongoing, Terminated, Completed, or a device recall's status.
classification	string	Drug and food recalls: Class I, Class II or Class III.
productType	string	Recalls: Drugs, Food, Devices. Labels: such as HUMAN PRESCRIPTION DRUG.
productDescription	string	Recalls: the recalled product as FDA describes it.
productCode	string	Device recalls and 510(k)s: FDA product code.
productQuantity	string	Recalls: quantity recalled.
codeInfo	string	Recalls: lots, serial numbers and expiry dates affected.
reasonForRecall	string	Recalls: why the product was recalled.
rootCause	string	Device recalls: the firm's root cause.
action	string	Device recalls: what the firm told customers to do.
recallingFirm	string	Recalls: the firm recalling the product.
city	string	Recalls and 510(k)s: the firm's city.
state	string	Recalls and 510(k)s: the firm's state.
country	string	Recalls and 510(k)s: the firm's country.
distributionPattern	string	Recalls: where the product was distributed.
voluntaryMandated	string	Drug and food recalls: whether the recall was voluntary or FDA-mandated.
recallInitiationDate	string	Recalls: when the recall started, YYYY-MM-DD.
reportDate	string	Recalls: when FDA published it (device recalls: date posted), YYYY-MM-DD.
terminationDate	string	Recalls: when the recall was closed, YYYY-MM-DD.
brandNames	array	Brand names (labels, approvals, and recalls FDA has linked to a product).
genericNames	array	Generic names (labels, approvals, and linked recalls).
deviceName	string	Device recalls and 510(k)s: the device's name.
deviceClass	string	Device recalls and 510(k)s: FDA device class, 1, 2 or 3.
kNumbers	array	Device recalls: the 510(k) clearances of the recalled device.
safetyReportId	string	Drug reports: the FAERS safety report ID.
receiveDate	string	Reports and 510(k)s: when FDA received it, YYYY-MM-DD.
serious	boolean	Drug reports: whether the report is serious.
seriousOutcomes	array	Drug reports: Death, Life threatening, Hospitalization, Disability, Congenital anomaly, Other serious.
reporterQualification	string	Drug reports: who reported it, such as Physician or Consumer or non-health professional.
reporterCountry	string	Drug reports: the reporter's country code.
occurCountry	string	Drug reports: where the event happened, as a country code.
patientSex	string	Reports: the patient's sex.
patientAge	number	Reports: the patient's age, in patientAgeUnit.
patientAgeUnit	string	Reports: years, months, weeks, days, hours or decades.
patientWeightKg	number	Drug reports: the patient's weight in kilograms.
drugs	array	Drug reports: each drug with name, role (Suspect, Concomitant, Interacting), indication, activeSubstance, dosage, brandNames, genericNames, manufacturers.
reactions	array	Drug and food reports: each reaction with its MedDRA term and, for drug reports, its outcome (such as Recovered/resolved or Fatal).
eventDate	string	Food and device reports: when the event happened, YYYY-MM-DD.
outcomes	array	Food and device reports: outcomes such as Hospitalization or Required Intervention.
products	array	Food reports: each product with name, role, industryCode, industryName. Approvals: each product with productNumber, brandName, activeIngredients (name, strength), dosageForm, route, marketingStatus, referenceDrug, teCode.
reportNumber	string	Device reports: the MDR report number.
eventType	string	Device reports: Malfunction, Injury, Death or Other.
reportSource	string	Device reports: who filed it, such as Manufacturer report.
eventLocation	string	Device reports: where it happened, such as HOSPITAL.
manufacturer	string	Device reports, labels and approvals: the manufacturer.
productProblems	array	Device reports: device problems, such as Incorrect Measurement.
devices	array	Device reports: each device with brandName, genericName, manufacturer, modelNumber, catalogNumber, lotNumber, productCode, deviceName, deviceClass, udi.
eventDescription	string	Device reports: the description of the event or problem.
manufacturerNarrative	string	Device reports: the manufacturer's narrative.
version	string	Labels: the label version.
effectiveDate	string	Labels: the label's effective date, YYYY-MM-DD.
routes	array	Labels: routes of administration, such as ORAL.
substanceNames	array	Labels: active substances.
pharmacologicClasses	array	Labels: established pharmacologic classes, such as GLP-1 Receptor Agonist [EPC].
productNdcs	array	Labels: product NDC codes.
applicationNumbers	array	Labels: the NDA, ANDA or BLA numbers the label belongs to.
boxedWarning	string	Labels: the boxed ("black box") warning.
indications	string	Labels: indications and usage.
dosage	string	Labels: dosage and administration.
contraindications	string	Labels: contraindications.
warnings	string	Labels: warnings and precautions.
adverseReactions	string	Labels: adverse reactions.
drugInteractions	string	Labels: drug interactions.
applicationNumber	string	Approvals: NDA, ANDA or BLA number, such as NDA209637.
sponsorName	string	Approvals: the application's sponsor.
approvalDate	string	Approvals: when the original application was approved, YYYY-MM-DD.
latestSubmissionDate	string	Approvals: the latest submission's status date, YYYY-MM-DD.
submissions	array	Approvals: submissions newest first, each with type, number, status, statusDate, classCode, classDescription, reviewPriority and documents (letters, labels, reviews with type, date, url).
kNumber	string	510(k)s: the K number, such as K253470.
applicant	string	510(k)s: the company that applied.
contact	string	510(k)s: the applicant's contact person.
decisionDate	string	510(k)s: decision date, YYYY-MM-DD.
decisionCode	string	510(k)s: decision code, such as SESE.
decisionDescription	string	510(k)s: the decision, such as Substantially Equivalent.
clearanceType	string	510(k)s: Traditional, Special or Abbreviated.
advisoryCommittee	string	510(k)s: the reviewing panel, such as Clinical Chemistry.
regulationNumber	string	510(k)s: the device regulation number, such as 880.5730.

💡 Use cases

• Pharmacovigilance and drug safety — pull every FAERS report on your products or a competitor's, with seriousness, reactions and outcomes, for signal detection.
• Recall monitoring — a daily feed of new Class I drug, device and food recalls, by product, firm or ingredient, for quality, supply-chain and retail compliance.
• Medical-device surveillance — track MAUDE malfunction and injury reports and device recalls for a product code or manufacturer.
• Regulatory and competitive intelligence — follow Drugs@FDA approvals, label changes, new boxed warnings and 510(k) clearances in a therapy area.
• Label analysis — compare indications, dosing, contraindications and warnings across every label of an ingredient.
• Research and journalism — build datasets on drug safety, recalls and approvals, and feed FDA text into search, RAG and LLM pipelines.

❓ FAQ

• Is this data reliable enough for medical decisions? No. openFDA states that its data must not be relied on to make decisions about medical care: treat every record as unvalidated. An adverse-event report does not prove that a product caused the event, and report counts cannot be used to estimate how often an event happens.
• Do I need an openFDA account or API key? No. Without a key, openFDA allows 1,000 requests a day per IP address; each request returns up to 1,000 recalls, approvals or 510(k)s, or 50 to 100 labels and reports. For larger runs, get a free key at open.fda.gov and enter it in apiKey to raise the limit to 120,000 a day.
• Do I need a proxy? No. It runs without one by default.
• How are results ordered? Newest first, by the dataset's main date, so maxItems keeps the most recent records.
• Why is url the same for every recall or drug report? FDA publishes no public page per drug or food recall, FAERS report or CAERS report, so those rows link to the dataset's openFDA page. Device recalls, MAUDE reports, labels, approvals and 510(k)s link to their own FDA or DailyMed page.
• Can I search one field only? Yes. Leave searchTerms empty and write the condition in searchQuery, for example recalling_firm:"Pfizer" or patient.drug.openfda.generic_name:"semaglutide".
• Can I paste FDA recall announcements? No. FDA press releases do not map to a record. Search the recalled product or firm instead, or paste the record page of a device recall, 510(k), MAUDE report, Drugs@FDA application or DailyMed label.
• Why are brand and generic names empty on some recalls? FDA links only some recalls to a product listing. The product is always in productDescription.

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🖼 Image credit

Image credit: open.fda.gov