La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System recall
FDA recall D-0418-2025 · initiated Mar 5, 2025
L'Oreal USA recalled La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System in Mar 2025 — an FDA Class II recall (D-0418-2025) 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.
Quantity recalled: 14,460 bottles
Details
- Product
- La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit).
- 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
Frequently asked
- Was La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System recalled?
- L'Oreal USA recalled La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System in Mar 2025 — an FDA Class II recall (D-0418-2025) 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 Dermatological Acne System recalled?
- Per the FDA enforcement record, the reason for recall D-0418-2025 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 Dermatological Acne System 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 Dermatological Acne System are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s, Expiration Dates: MYX30W, Exp 03/31/2025 MYX32W, Exp 03/31/2025 MYX33W, Exp 03/31/2025 MYX41W, Exp 04/30/2025 MYX42W, Exp 04/30/2025 MYX43W, Exp 04/30/2025 MYX44W, Exp 04/30/2025 MYX45W, Exp 04/30/2025 MYX50W, Exp 05/31/2025 MYX51W, Exp 04/30/2025 MYX52W, Exp 04/30/2025 MYX53W, Exp 05/31/2025 MYX70W, Exp 07/31/…. 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-0418-2025.