Drug & Device Safety Atlas
Class II FDA drug recall · D-0419-2025

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 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.

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
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

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-0419-2025
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-0419-2025 · Source: openFDA enforcement.