L'Oreal product recalled over manufacturing violations

Recall date

March 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

L'Oreal USA recalls La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel C…

Recall number

D-0418-2025

FDA classification

Class II

Brand / firm

L'Oreal USA

Sold / distributed

Nationwide in the USA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).