openFDA drug recall enforcement by FIRM/state/class (distinct from by-drug lookups) API

Queries openFDA DRUG enforcement reports by recalling FIRM, state, classification and/or date — the manufacturer/recall-event lens, distinct from existing by-drug-name safety lookups. Normalized with Class->severity. Answers 'what has <pharma firm> recalled?', 'any Class I drug recalls in <state>?'.

Price$0.01per request

MethodPOST

Route/v1/gov/fda-drug-enforcement-by-firm

StatusLive

MIME typeapplication/json

Rate limit60/minute

Cache3600s public

govrecallsfdaopenfdadrugenforcementfirmseverity

API URLhttps://x402.hexl.dev/v1/gov/fda-drug-enforcement-by-firm

Integration docs

Example request

{
  "firm": "Pfizer",
  "limit": 2
}

Example response

{
  "query": "Pfizer",
  "totalRecalls": 2,
  "bySource": {
    "FDA": 2
  },
  "bySeverity": {
    "critical": 0,
    "high": 1,
    "moderate": 0,
    "low": 1,
    "unknown": 0
  },
  "aggregateRiskScore": 40,
  "aggregateRiskClass": "moderate",
  "worstRecall": {
    "source": "FDA",
    "recallId": "D-1487-2019",
    "date": "2019-07-09",
    "title": "Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA,  NDC 0409-2776-23, Barcode (01)00304092776233.",
    "firm": "Pfizer Inc.",
    "productType": "drugs",
    "hazard": "Lack of Assurance of Sterility: Bags have the potential to leak.",
    "remedy": null,
    "units": "280340 bags",
    "status": "Terminated",
    "severityScore": 55,
    "severityClass": "high",
    "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1487-2019"
  },
  "totalMatching": 155,
  "recalls": [
    {
      "source": "FDA",
      "recallId": "D-1487-2019",
      "date": "2019-07-09",
      "title": "Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA,  NDC 0409-2776-23, Barcode (01)00304092776233.",
      "firm": "Pfizer Inc.",
      "productType": "drugs",
      "hazard": "Lack of Assurance of Sterility: Bags have the potential to leak.",
      "remedy": null,
      "units": "280340 bags",
      "status": "Terminated",
      "severityScore": 55,
      "severityClass": "high",
      "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1487-2019"
    },
    {
      "source": "FDA",
      "recallId": "D-1443-2014",
      "date": "2014-07-08",
      "title": "VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company,  Distributed by: ViV Healthcare Company, Research Triang",
      "firm": "Pfizer Inc.",
      "productType": "drugs",
      "hazard": "Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016.  The correct expiry date is 09/2016.",
      "remedy": null,
      "units": "1200  tablets",
      "status": "Terminated",
      "severityScore": 25,
      "severityClass": "low",
      "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1443-2014"
    }
  ]
}

Input schema

{
  "type": "object",
  "properties": {
    "firm": {
      "type": "string",
      "description": "Recalling firm name, e.g. 'Pfizer'."
    },
    "state": {
      "type": "string",
      "description": "Two-letter US state of the firm."
    },
    "classification": {
      "type": "string",
      "description": "'Class I', 'Class II', or 'Class III'."
    },
    "since": {
      "type": "string",
      "description": "Earliest report date, YYYY-MM-DD."
    },
    "limit": {
      "type": "number",
      "description": "Max recalls (1-50, default 20)."
    }
  }
}

Output schema

{
  "type": "object",
  "additionalProperties": true
}