La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication
Summary
The FDA issued a Class II for La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen by L'Oreal USA. Reason: 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 ab.
Details
Source
Drug Recall
External ID
D-0419-2025
Action Date
2025-05-21
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: 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
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-05
Company
Clark, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
L'Oreal USA has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (L'Oreal USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does L'Oreal USA have FDA actions?
L'Oreal USA has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0419-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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