openFDA Recalls, Enforcement & Adverse Events

Seven public FDA datasets in one actor: 20,692,690 drug adverse-event reports, 151,589 food adverse events, 59,494 device recall records, 57,278 device premarket approvals, and 87,744 recall enforcement reports across devices (40,249), food (29,485) and drugs (18,010). Counts measured from the live API on 20 October 2026.

Each record carries the recall or approval identity, dates, classification, status, firm, product description, reason, location and the source link.

Low cost

From $0.00005 per record, down to $0.00003 at Gold. Pay only for the records you receive.

What you get

field	meaning
corpus	which FDA dataset the row came from
recordId	recall number, product recall number, PMA number or report number
reportDate, eventDate	published and event dates
classification	Class I, Class II, Class III (enforcement), Serious / Non-serious (drug events), grade where published
status	Ongoing / Terminated, recall status, PMA decision code, or event outcome
productType, productDescription	device / drug, or the food industry, and the product
reason	reason for recall, root cause, adverse reactions
firm	recalling firm or PMA applicant (enforcement, recall and PMA corpora; blank for adverse events)
city, state, country, postalCode	firm location (enforcement, recall and PMA corpora; blank for adverse events)
distribution, quantity, eventId, notification, action	recall depth where published
sourceUrl, refreshedDate	FDA endpoint and its last-updated date

Search it

• Keyword - free text across firm, product and reason.
• Firm - firm="Medtronic".
• Class - classification="Class I" for the most serious recalls.
• Status - status="Ongoing" or "Terminated".
• Geography - state="MA", country="United States".
• Date window - dateFrom / dateTo (YYYY-MM-DD).
• Drug adverse events - serious="Serious".

Example inputs

Device recalls from one firm

{ "corpus": "device-enforcement", "firm": "Medtronic", "maxResults": 25 }

Class I recalls in a date window

{ "corpus": "device-enforcement", "classification": "Class I",
  "dateFrom": "2025-01-01", "maxResults": 50 }

Food adverse events for a product

{ "corpus": "food-event", "keyword": "gummy", "dateFrom": "2025-01-01" }

Serious drug adverse events mentioning aspirin

{ "corpus": "drug-event", "keyword": "aspirin", "serious": "Serious",
  "dateFrom": "2025-01-01", "maxResults": 25 }

Premarket approvals for one applicant

{ "corpus": "device-pma", "firm": "Abbott", "maxResults": 25 }

Counts by class - mode=aggregate.

{ "mode": "aggregate", "corpus": "device-enforcement",
  "groupBy": "classification" }

Counts by state - groupBy=state, country, status or productType.

{ "mode": "aggregate", "corpus": "food-enforcement",
  "groupBy": "state" }

Example output

Long text fields are trimmed here; real rows carry the full source value.

{
 "corpus": "device-enforcement",
 "recordId": "Z-2372-2023",
 "reportDate": "2023-08-23",
 "eventDate": "2023-06-28",
 "classification": "Class I",
 "status": "Ongoing",
 "productType": "Devices",
 "productDescription": "MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter",
 "reason": "Catheter center lumen was found to have an occlusion",
 "action": "Letter",
 "firm": "Covidien LP",
 "city": "Mansfield",
 "state": "MA",
 "country": "United States",
 "postalCode": "02048-1113",
 "eventId": "92660",
 "notification": "Voluntary: Firm initiated",
 "sourceUrl": "https://api.fda.gov/device/enforcement.json",
 "refreshedDate": "2026-10-07"
}

Notes on the data, from the source

• Aggregation covers the three enforcement corpora (device, food, drug). The recall, PMA and adverse-event corpora support search only.
• Paging limit. One query can return at most 25,000 records; maxResults above that is rejected rather than silently clamped. Add a date window or a more specific filter to cover a larger set.
• No ordering. The API does not expose a sort control, so search returns the source's own order. Use a date window and maxResults for a bounded result.
• Adverse events are de-identified. Patient demographics, narratives and reporter details are not returned. Drug event records carry the product, reactions, outcome, seriousness classification and dates; food event records carry the product, reactions, outcome and dates. firm and location are blank on both; food events also leave classification blank.
• Not medical advice. openFDA states that results are unvalidated and must not be relied on for clinical decisions.
• Licence. openFDA data is a U.S. Government work in the public domain.

Data source: api.fda.gov (U.S. Food and Drug Administration).