CLASS II ONGOING Drug recall · Reported 21 May 2025 · FDA Enforcement Report
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual recalled
L'Oreal USA is recalling La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5%, 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-0419-2025
- 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 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.
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?
a) Lot #s, Expiration dates: MYX30W 03/2025 MYX43W 04/2025 MYX41W 04/2025 MYX42W 04/2025 MYX40W 04/2025 MYX51W 05/2025 MYX50W 05/2025 MYX60W 05/2025 MYX71W 06/2025 MYX90W 08/2025 MYX91W 09/2025 MYX92W 08/2025 MYXO0W 09/2025 MYX93W 09/2025 MYXD1W 11/2025 MYXD2W 11/2025 MYXDOW 09/2025 MYXD4W 11/2025 MYXD3W 11/2025 MYY22W 02/2026 MYY21W 02/2026 MYY20W 02/2026 MYY41W 04/2026 MYY40W 04/2026 MYY42W 04/2026 MYY43W 04/2026 MYY52W 05/2026 MYY51W 05/2026 MYY50W 05/2026 MYY60W 06/2026 b) Lot #s, Expiration dates MYX31W 3/2025 MYX32W 3/2025 MYX33W 3/2025 MYX34W 3/2025 MYX35W 3/2025 MYX40W 3/2025 MYX41W 4/2025 MYX42W 4/2025 MYX44W 4/2025 MYX45W 4/2025 MYX47W 4/2025 MYX48W 4/2025 MYX49W 4/2025 MYX50W 5/2025 MYX51W 5/2025 MYX52W 5/2025 MYX70W 6/2025 MYX71W 6/2025 MYX72W 7/2025 MYX73W 7/2025 MYX74W 7/2025 MYX75W 7/2025 MYX77W 7/2025 MYX78W 7/2025 MYX80W 8/2025 MYX81W 7/2025 MYX82W 8/2025 MYX83W 8/2025 MYX84W 7/2025 MYXO0W 9/2025 MYXO1W 8/2025 MYXO3W 8/2025 MYXO4W 9/2025 MYXO5W 9/2025 MYXO7W 9/2025 MYXO8W 8/2025 MYXO9W 9/2025 MYXD0W 11/2025 MYXD1W 12/2025 MYXD2W 11/2025 MYXD3W 11/2025 MYXD4W 11/2025 MYXD5W 11/2025 MYXD6W 12/2025 MYY22W 02/2026 MYY23W 02/2026 MYY30W 02/2026 MYY31W 03/2026 MYY32W 03/2026 MYY40W 03/2026 MYY41W 04/2026 MYY42W 04/2026 MYY43W 04/2026 MYY51W 04/2026 MYY60W 06/2026 MYY61W 06/2026 MYY62W 06/2026 MYY63W 06/2026 MYY64W 06/2026 MYY65W 06/2026 MYY66W 06/2026
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 96390| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | La Roche-Posay Laboratoire Dermatologique Effaclar recalled by L'Oreal U | 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 recalled by L'Oreal U | L'Oreal USA | Benzene | Nationwide |