FDA Recall D-0417-2025

L'Oreal USA · Clark, NJ

Class II Ongoing 435 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.

Lot / code: Lot #: MYX46W, Exp 04/30/2025

Quantity: 2,226,801 bottles

Reason for recall

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Recall record

Recall number: D-0417-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-03-05
Classified by FDA Center: 2025-05-09
FDA published: 2025-05-21
Recalling firm: L'Oreal USA
Firm location: Clark, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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