# FDA recall D-0418-2025

> **L'Oreal USA** · Class II · drug recall initiated 2025-03-05.

## 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).

## Reason for recall

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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0418-2025
- **Recalling firm:** L'Oreal USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-05
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clark, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0418-2025

## Citation

> AI Analytics. FDA recall D-0418-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0418-2025. Source: US FDA. Licensed CC0.

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