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Home Drug Recalls D-0418-2025
Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System

Recalling Firm / Manufacturer: L'Oreal USA (Clark, NJ, United States)
FDA Recall Number: D-0418-2025
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
14,460 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

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.

Full Product Description
Packaging specifications and labeling details

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).

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 21, 2025
Firm Initiation Date
March 05, 2025
FDA Classification Date
May 09, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
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.
Distribution Information
Geographic scope of affected shipments

Nationwide in the USA

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0418-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508616UTCC
View Official FDA Source

System Notice

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