Drug & Device Safety Atlas
Class II FDA drug recall · D-0418-2025

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 risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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).

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
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 07/31/2025 MYX80W, Exp 07/31/2025 MYX81W, Exp 07/31/2025 MYX90W, Exp 08/31/2025 MYX91W, Exp 08/31/2025 MYX92W, Exp 08/31/2025 MYX93W, Exp 08/31/2025 MYXD0W, Exp 09/30/2025 MYXO1W, Exp 09/30/2025 MYXO2W, Exp 09/30/2025 MYXO3W, Exp 09/30/2025 MYXO4W, Exp 09/30/2025 MYXO5W, Exp 09/30/2025 MYY21W, Exp 02/28/2026 MYY23W, Exp 02/28/2026 MYY26W, Exp 02/28/2026 MYY27W, Exp 02/28/2026 MYY31W, Exp 03/31/2026 MYY32W, Exp 11/30/2025 MYY33W, Exp 11/30/2025 MYY34W, Exp 03/31/2026 MYY50W, Exp 05/31/2026 MYY51W, Exp 05/31/2026 MYY60W, Exp 05/31/2026 MYY61W, Exp 03/31/2026 MYY62W, Exp 06/30/2026 MYY63W, Exp 06/30/2026 MYY64W, Exp 06/30/2026 MYY72W, Exp 06/30/2026 MYY73W, Exp 06/30/2026 MYY74W, Exp 06/30/2026 MYY75W, Exp 06/30/2026 MYY76W, Exp 06/30/2026.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Nationwide in the USA

Recall record

Recalling firm
L'Oreal USA
Product type
Drugs
Recall number
D-0418-2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Clark, NJ
Recall initiated
2025-03-05

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall D-0418-2025 · Source: openFDA enforcement.