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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0419-2025.jsonld",
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  "name": "La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.",
  "description": "FDA recall D-0419-2025 — L'Oreal USA is recalling La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France. (Drugs, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0419-2025&lang=eng",
  "about": {
    "@type": "schema:Drug",
    "name": "La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.",
    "manufacturer": {
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      "name": "L'Oreal USA"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0419-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall D-0419-2025: L'Oreal USA is recalling La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.",
      "text": "The FDA logged enforcement record D-0419-2025: L'Oreal USA is voluntarily recalling La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France. — reason: cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-05. Affected lots/codes: a) Lot #s, Expiration dates: MYX30W 03/2025 MYX43W 04/2025 MYX41W 04/2025 MYX42W 04/2025 MYX40W 04/2025 MYX51W 05/2025 MYX50W 05/2025 MYX60W 05/2025 MYX71W 06/2025 MYX90W 08/2025 MYX91W 09/2025 MYX92W 08/2025 MYXO0W 09/2025 MYX93W  09/2025 MYXD1W  11/2025 MYXD2W  11/2025 MYXDOW 09/2025 MYXD4W  11/2025 MYXD3W  11/2025 MYY22W  02/2026 MYY21W  02/2026 MYY20W  02/2026 MYY41W  04/2026 MYY40W  04/2026 MYY42W  04/2026 MYY43W  04/2026 MYY52W  05/2026 MYY51W  05/2026 MYY50W  05/2026 MYY60W  06/2026  b) Lot #s, Expiration dates MYX31W  3/2025  MYX32W  3/2025  MYX33W  3/2025  MYX34W  3/2025  MYX35W  3/2025  MYX40W  3/2025  MYX41W  4/2025  MYX42W  4/2025  MYX44W  4/2025  MYX45W  4/2025   MYX47W  4/2025  MYX48W  4/2025  MYX49W  4/2025  MYX50W  5/2025  MYX51W  5/2025  MYX52W  5/2025  MYX70W  6/2025  MYX71W  6/2025  MYX72W  7/2025  MYX73W  7/2025  MYX74W  7/2025  MYX75W  7/2025  MYX77W  7/2025  MYX78W  7/2025  MYX80W  8/2025  MYX81W  7/2025  MYX82W  8/2025  MYX83W  8/2025  MYX84W  7/2025  MYXO0W  9/2025  MYXO1W  8/2025  MYXO3W  8/2025  MYXO4W  9/2025  MYXO5W  9/2025  MYXO7W  9/2025  MYXO8W  8/2025  MYXO9W  9/2025  MYXD0W  11/2025  MYXD1W  12/2025  MYXD2W  11/2025  MYXD3W  11/2025  MYXD4W  11/2025  MYXD5W  11/2025  MYXD6W  12/2025  MYY22W  02/2026  MYY23W  02/2026  MYY30W  02/2026  MYY31W  03/2026  MYY32W  03/2026  MYY40W  03/2026  MYY41W  04/2026  MYY42W  04/2026  MYY43W  04/2026  MYY51W  04/2026  MYY60W  06/2026  MYY61W  06/2026  MYY62W  06/2026  MYY63W  06/2026  MYY64W    06/2026 MYY65W    06/2026 MYY66W    06/2026. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0419-2025&lang=eng",
        "value": "Drugs recall, status Ongoing",
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      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0419-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall D-0419-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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        "supported": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0419-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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      "name": "FDA recall details — D-0419-2025",
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            "Value": "D-0419-2025",
            "Status": "recorded"
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            "Value": "Drugs",
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "L'Oreal USA",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-03-05",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) Lot #s, Expiration dates: MYX30W 03/2025 MYX43W 04/2025 MYX41W 04/2025 MYX42W 04/2025 MYX40W 04/2025 MYX51W 05/2025 MYX50W 05/2025 MYX60W 05/2025 MYX71W 06/2025 MYX90W 08/2025 MYX91W 09/2025 MYX92W 08/2025 MYXO0W 09/2025 MYX93W  09/2025 MYXD1W  11/2025 MYXD2W  11/2025 MYXDOW 09/2025 MYXD4W  11/2025 MYXD3W  11/2025 MYY22W  02/2026 MYY21W  02/2026 MYY20W  02/2026 MYY41W  04/2026 MYY40W  04/2026 MYY42W  04/2026 MYY43W  04/2026 MYY52W  05/2026 MYY51W  05/2026 MYY50W  05/2026 MYY60W  06/2026  b) Lot #s, Expiration dates MYX31W  3/2025  MYX32W  3/2025  MYX33W  3/2025  MYX34W  3/2025  MYX35W  3/2025  MYX40W  3/2025  MYX41W  4/2025  MYX42W  4/2025  MYX44W  4/2025  MYX45W  4/2025   MYX47W  4/2025  MYX48W  4/2025  MYX49W  4/2025  MYX50W  5/2025  MYX51W  5/2025  MYX52W  5/2025  MYX70W  6/2025  MYX71W  6/2025  MYX72W  7/2025  MYX73W  7/2025  MYX74W  7/2025  MYX75W  7/2025  MYX77W  7/2025  MYX78W  7/2025  MYX80W  8/2025  MYX81W  7/2025  MYX82W  8/2025  MYX83W  8/2025  MYX84W  7/2025  MYXO0W  9/2025  MYXO1W  8/2025  MYXO3W  8/2025  MYXO4W  9/2025  MYXO5W  9/2025  MYXO7W  9/2025  MYXO8W  8/2025  MYXO9W  9/2025  MYXD0W  11/2025  MYXD1W  12/2025  MYXD2W  11/2025  MYXD3W  11/2025  MYXD4W  11/2025  MYXD5W  11/2025  MYXD6W  12/2025  MYY22W  02/2026  MYY23W  02/2026  MYY30W  02/2026  MYY31W  03/2026  MYY32W  03/2026  MYY40W  03/2026  MYY41W  04/2026  MYY42W  04/2026  MYY43W  04/2026  MYY51W  04/2026  MYY60W  06/2026  MYY61W  06/2026  MYY62W  06/2026  MYY63W  06/2026  MYY64W    06/2026 MYY65W    06/2026 MYY66W    06/2026",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide in the USA",
            "Status": "recorded"
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}