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Recall Observatory FDA recall evidence

Drug 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.

D-0417-2025

March 05, 2025

Class II

Product summary

Firm
L'Oreal USA
Event
Event 96390
Status
Ongoing
Classification
Class II
Quantity
2,226,801 bottles
Official record key
drug-enforcement:D-0417-2025

Official wording

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

Code information: Lot #: MYX46W, Exp 04/30/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination