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Class II: temporary or reversible health riskOngoing

L'Oreal La Roche-Posay Laboratoire Dermatologique Recall

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5

L'Oreal USA · Clark, NJ

Risk level
Class II
Reported by FDA
May 21, 2025
Recall ID
D-0417-2025
Check your lot numberHow we source this data

Summary

L'Oreal recalled La Roche-Posay Laboratoire Dermatologique starting Mar 5, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0417-2025 on May 21, 2025. Reason: Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. Status: Ongoing.

Why it was recalled

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Product description

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.

Lot numbers, UPCs & expiration codes

Lot #: MYX46W, Exp 04/30/2025

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0417-2025
Classification
Class II
Status
Ongoing
Recall initiated
Mar 5, 2025
FDA report date
May 21, 2025
Quantity
2,226,801 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
L'Oreal USA

Original FDA data

Every field from FDA enforcement report D-0417-2025, exactly as published.

Show all FDA fields
City
Clark
State
NJ
Status
Ongoing
Country
United States
Event ID
96390
Address
222 Terminal Ave
Code information
Lot #: MYX46W, Exp 04/30/2025
Postal code
07066-1317
Report date
May 21, 2025
Product type
Drugs
Recall number
D-0417-2025
Classification
Class II
Recalling firm
L'Oreal USA
Product quantity
2,226,801 bottles
Reason for recall
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Voluntary / mandated
Voluntary: Firm initiated
Product description
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.
Distribution pattern
Nationwide in the USA
Recall initiation date
Mar 5, 2025
Initial firm notification
Letter
Center classification date
May 9, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0417-2025, published May 21, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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