FDA recall D-0419-2025

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.

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-0419-2025