FDA recall D-0418-2025

L'Oreal USA · Class II · drug

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

Status
Ongoing
Initiation date
2025-03-05
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clark, NJ, United States

Primary source

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