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, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.
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.
Recall record
Recall number
D-0419-2025
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.