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La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment recall

FDA recall D-0419-2025 · initiated Mar 5, 2025

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated May 21, 2025How we research

L'Oreal USA recalled La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… in Mar 2025 — an FDA Class II recall (D-0419-2025) because 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.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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.

Something got into the product

A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

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

Details

Product
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.
Recalling company
L'Oreal USA
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Mar 5, 2025
FDA report date
May 21, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… recalled?
L'Oreal USA recalled La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… in Mar 2025 — an FDA Class II recall (D-0419-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
Why was La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… recalled?
Per the FDA enforcement record, the reason for recall D-0419-2025 was: 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.
Is a recalled La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen… are affected?
Distributed: Nationwide in the USA. The recall covers these lots — 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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0419-2025.

Source: openFDA Drug Enforcement record D-0419-2025

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