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Latest US Drug Recalls (openFDA Enforcement Reports)

Most recent FDA drug recalls with classification (Class I-III), firm, product and reason; optional product search term.

Call it (no API key)

GET https://api.agentdatahub.de/api/v1/call/fda-drug-recalls?limit=10&compact=1

Full metadata: without compact=1 · Markdown: format=llm · Only some fields: add &fields=a,b.c · MCP: tool call_api with {"apiId":"fda-drug-recalls"}

Parameters

qOptional product search term
limit1-20 (default: 10)

Example response (live, compact)

{
  "apiId": "fda-drug-recalls",
  "data_freshness": "cached",
  "data": {
    "recalls": [
      {
        "report_date": "20261021",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Houston Rx LLC",
        "product": "Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",
        "reason": "Lack of process control",
        "country": "United States"
      },
      {
        "report_date": "20261021",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Teva Pharmaceuticals USA, Inc",
        "product": "Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054.  NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05",
        "reason": "Presence of Foreign Tablets/Capsules",
        "country": "United States"
      },
      {
        "report_date": "20261021",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "American Health Packaging",
        "product": "Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.  NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11",
        "reason": "Presence of Foreign Tablets/Capsules",
        "country": "United States"
      },
      {
        "report_date": "20261021",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Zydus Pharmaceuticals (USA) Inc",
        "product": "Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pe",
        "reason": "Failed Impurities/Degradation Specifications.",
        "country": "United States"
      },
      {
        "report_date": "20261021",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Houston Rx LLC",
        "product": "Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",
        "reason": "Lack of assurance of sterility.",
        "country": "United States"
      },
      {
        "report_date": "20261014",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "K.C. Pharmaceuticals, Inc.",
        "product": "Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Cr",
        "reason": "Lack of Assurance of Sterility",
        "country": "United States"
      },
      {
        "report_date": "20261014",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Carolina Infusion, LLC",
        "product": "QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,",
        "reason": "Lack of Assurance of Sterility:   Related to processing equipment used in compounded product.",
        "country": "United States"
      },
      {
        "report_date": "20261014",
        "classification": "Class II",
        "status": "Ongoing",
        "firm": "Carolina Infusion, LLC",
        "product": "TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Roa",
        "reason": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
        "country": "United States"
      },
      {
        "report_date": "20261014",
        "classification": "Cl
… (truncated)

Recorded history available: /api/v1/history/fda-drug-recalls?limit=10

Source & license

SourceU.S. FDA openFDA
LicenseCC0 Public Domain (openFDA)
Source URLhttps://api.fda.gov/drug/enforcement.json
Termshttps://open.fda.gov/terms/
CategoryLaw, Compliance, Health & Nutrition Science › Drug & Food Safety (openFDA)