La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological… — Class II drug recall D-0418-2025
Ongoing recall by L'Oreal USA, reported 2025-05-21, distributed nationwide. cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this pr
| Recall number | D-0418-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | L'Oreal USA, Clark, NJ, United States |
| Recall initiated | 2025-03-05 |
| Classified | 2025-05-09 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 14,460 bottles |
| Reason classes | chemical contamination, cgmp |
| UPC / GTIN / UDI-DI | 00883140035275, 00883140035282 |
| Lot numbers | MYX30W, MYX32W, MYX33W, MYX41W, MYX42W, MYX43W, MYX44W, MYX45W, MYX50W, MYX51W, MYX52W, MYX53W, MYX70W, MYX80W, MYX81W, MYX90W, MYX91W, MYX92W, MYX93W, MYXD0W, MYXO1W, MYXO2W, MYXO3W, MYXO4W, MYXO5W, MYY21W, MYY23W, MYY26W, MYY27W, MYY31W, MYY32W, MYY33W, MYY34W, MYY50W, MYY51W, MYY60W, MYY61W, MYY62W, MYY63W, MYY64W and 5 more |
| Expiration dates | 2025-03-31, 2025-04-30, 2025-05-31, 2025-07-31, 2025-08-31, 2025-09-30, 2025-11-30, 2026-02-28, 2026-03-31, 2026-05-31, 2026-06-30 |
Product
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0418-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.