CLASS II ONGOING Drug recall · Reported 21 May 2025 · FDA Enforcement Report
La Roche-Posay Laboratoire Dermatologique Effaclar recalled by L'Oreal U
L'Oreal USA is recalling La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step, distributed nationwide in the US. The recall was initiated on 5 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0418-2025
- FDA event ID
- 96390
- Recalling firm
- L'Oreal USA, Clark, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Mar 2025
- FDA classified
- 9 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Benzene
- Drug class
- Creams, Ointments & Gels
Timeline
| 5 Mar 2025 | Recall initiated by company | |
| 9 May 2025 | Classified by FDA | +65 days |
| 21 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96390This product is part of a recall event; the main page for the event is La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled | L'Oreal USA | Benzene | Nationwide | |
| CLASS II | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled | L'Oreal USA | Benzene | Nationwide |
More recalls from L'Oreal USA
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled | L'Oreal USA | Benzene | Nationwide |
| Drug | CLASS II | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled | L'Oreal USA | Benzene | Nationwide |