FDA Recalls & Enforcement Actions — Drugs, Medical Devices & Food

Extract official US Food and Drug Administration (FDA) recall enforcement reports from the openFDA Enforcement API covering Drugs, Medical Devices, and Food products.

Monitor Class I, II, and III recalls, recalling firms, lot/serial numbers (codeInfo), reason for recall, product quantities, nationwide/international distribution patterns, and recall status.

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Data Sources

Queries the official openFDA Enforcement endpoints directly:

• Drugs: https://api.fda.gov/drug/enforcement.json
• Medical Devices: https://api.fda.gov/device/enforcement.json
• Food & Beverages: https://api.fda.gov/food/enforcement.json

FDA Recall Classifications

Classification	Severity	Meaning
Class I	Critical	Dangerous or defective products that predictably could cause serious health problems or death.
Class II	Moderate	Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
Class III	Minor	Products that are unlikely to cause any adverse health reaction, but violate FDA labeling or manufacturing laws.

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Input Parameters

Parameter	Type	Default	Description
categories	string[]	["drug", "device", "food"]	FDA enforcement categories to query (drug, device, food).
searchQuery	string	""	Keyword searched across product_description and reason_for_recall (e.g. "salmonella", "sterility", "undeclared").
firm	string	""	Filter by recalling firm name (recalling_firm), e.g. "Pfizer", "Medtronic", "Abbott".
classification	string	"all"	Filter by hazard severity: "all", "Class I", "Class II", or "Class III".
status	string	"all"	Filter by enforcement status: "all", "Ongoing", "Completed", "Terminated", or "Pending".
country	string	""	Filter by recalling firm country (e.g. "United States", "India", "Canada").
state	string	""	Filter by 2-letter US state code (e.g. "CA", "NJ", "TX").
dateFrom	string	"2026-01-01"	Earliest report_date (YYYY-MM-DD).
dateTo	string	""	Latest report_date (YYYY-MM-DD). Leave empty for today.
maxItems	integer	500	Maximum total enforcement records to output across all selected categories (1–25000).
proxy	object	(optional)	Optional Apify Proxy configuration.

Example Input

{
  "categories": ["drug", "device", "food"],
  "classification": "Class I",
  "status": "Ongoing",
  "dateFrom": "2026-01-01",
  "maxItems": 200
}

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Output Format

Each dataset item contains structured enforcement metadata, OpenFDA brand/generic/manufacturer enrichments, and formatted dates (YYYY-MM-DD):

{
  "category": "food",
  "recallNumber": "F-0412-2026",
  "eventId": "95812",
  "status": "Ongoing",
  "classification": "Class I",
  "classificationMeaning": "Dangerous or defective products that predictably could cause serious health problems or death.",
  "recallingFirm": "Example Foods LLC",
  "brandNames": "NatureHarvest",
  "genericNames": null,
  "manufacturerNames": "Example Foods LLC",
  "productType": "Food",
  "productDescription": "Organic Creamy Peanut Butter, 16 oz (454g) glass jars, UPC 0-12345-67890-1",
  "productQuantity": "14,200 cases",
  "reasonForRecall": "Product has the potential to be contaminated with Salmonella.",
  "voluntaryOrMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "Press Release",
  "distributionPattern": "Distributed nationwide in the US to retail grocery stores.",
  "city": "Fresno",
  "state": "CA",
  "country": "United States",
  "postalCode": "93721",
  "address": "1200 Industrial Way",
  "recallInitiationDate": "2026-02-10",
  "centerClassificationDate": "2026-02-24",
  "reportDate": "2026-03-04",
  "terminationDate": null,
  "codeInfo": "Lot codes: NH2601A, NH2601B; Best By 01/2027",
  "sourceUrl": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0412-2026%22",
  "scrapedAt": "2026-04-17T10:00:00.000Z"
}

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Use Cases

• Healthcare & Hospital Supply Chain Compliance: Automatically cross-reference hospital inventory and pharmacy formularies against ongoing Class I & II drug and medical device recalls.
• Food & Grocery Retail Quality Assurance: Track undeclared allergen alerts, Listeria/Salmonella/E. coli recalls, and affected lot numbers (codeInfo).
• Pharmaceutical & MedTech Competitive Intelligence: Analyze enforcement history by manufacturer (firm), state/country, or failure mode (e.g., cGMP deviations, sterility, particulate matter).
• Automated Risk & Legal Monitoring: Schedule daily runs with dateFrom to feed new FDA enforcement actions into compliance workflows.

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Notes

• Automatic Pagination: Seamlessly paginates through openFDA results in batches of 100 up to maxItems.
• Clean Normalized Dates: Converts FDA's raw YYYYMMDD dates into standard ISO YYYY-MM-DD strings.