FDAFDA · Food and drugs·Recall number D-0418-2025
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).
Published May 21, 2025 · Recall initiated: March 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- L'Oreal USA
- Distributor
- Nationwide in the USA
- Lot
- Lot #s, Expiration Dates: MYX30W, Exp 03/31/2025 MYX32W, Exp 03/31/2025 MYX33W, Exp 03/31/2025 MYX41W, Exp 04/30/2025 MYX42W, Exp 04/30/2025 MYX43W, Exp 04/30/2025 MYX44W, Exp 04/30/2025 MYX45W, Exp 04/30/2025 MYX50W, Exp 05/31/2025 MYX51W, Exp 04/30/2025 MYX52W, Exp 04/30/2025 MYX53W, Exp 05/31/2025 MYX70W, Exp 07/31/2025 MYX80W, Exp 07/31/2025 MYX81W, Exp 07/31/2025 MYX90W, Exp 08/31/2025 MYX91W, Exp 08/31/2025 MYX92W, Exp 08/31/2025 MYX93W, Exp 08/31/2025 MYXD0W, Exp 09/30/2025 MYXO1W, Exp 09/30/2025 MYXO2W, Exp 09/30/2025 MYXO3W, Exp 09/30/2025 MYXO4W, Exp 09/30/2025 MYXO5W, Exp 09/30/2025 MYY21W, Exp 02/28/2026 MYY23W, Exp 02/28/2026 MYY26W, Exp 02/28/2026 MYY27W, Exp 02/28/2026 MYY31W, Exp 03/31/2026 MYY32W, Exp 11/30/2025 MYY33W, Exp 11/30/2025 MYY34W, Exp 03/31/2026 MYY50W, Exp 05/31/2026 MYY51W, Exp 05/31/2026 MYY60W, Exp 05/31/2026 MYY61W, Exp 03/31/2026 MYY62W, Exp 06/30/2026 MYY63W, Exp 06/30/2026 MYY64W, Exp 06/30/2026 MYY72W, Exp 06/30/2026 MYY73W, Exp 06/30/2026 MYY74W, Exp 06/30/2026 MYY75W, Exp 06/30/2026 MYY76W, Exp 06/30/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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