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RECALL RECORD — CLASS IIIRecall closedD-048-2013/FDA enforcement
Valeant Pharmaceuticals·Cosmetics·Oct 15, 2012

Acnefree Severe Maximum Strength Acne Pore Cleanser (Benzoyl Peroxide 5% W/v), 3 OZ (85 G)…

What you need to know

Class III

  • What happened

    Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label…

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • Action required

    Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.

Recall closed · classified by the FDANationwide (US)More cosmetics

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Match before you discard

Product identification

Source: FDA COSMETICS

Brand nameValeant Pharmaceuticals
Recalling firmValeant PharmaceuticalsBridgewater, NJ, United States
UPC / barcodes
7 88521 13550 97 88521 13350 9
Lot / date codes
  • All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
Distribution area
Nationwide

Nationwide

United States

Quantity affected10, 434 canisters
Recall initiationFDA report date: November 14, 2012
FDA recall numberD-048-2013

Beyond the headline

The recall, in context

Valeant Pharmaceuticals initiated this cosmetics recall on October 15, 2012. The FDA enforcement report states: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. The FDA report lists distribution as: Nationwide.

The FDA enforcement report describes the reason as: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Acnefree Severe Maximum Strength Acne Pore Cleanser (Benzoyl Peroxide 5% W/v), 3 OZ (85 G)… was made or distributed by Valeant Pharmaceuticals in Bridgewater, NJ, United States. This page reflects FDA report D-048-2013, dated November 14, 2012.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

What to do now

  1. 1

    Stop using it

    Set the product aside and do not apply it.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Acnefree Severe Maximum Strength Acne Pore Cleanser (Benzoyl Peroxide 5% W/v), 3 OZ (85 G)… recall?

Valeant Pharmaceuticals recalled Acnefree Severe Maximum Strength Acne Pore Cleanser (Benzoyl Peroxide 5% W/v), 3 OZ (85 G)… in an FDA Class III enforcement action reported as D-048-2013. Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label…

What should I do if I bought this product?

Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

Is the Valeant Pharmaceuticals recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-048-2013. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

More recalls by Valeant Pharmaceuticals

View brand
Class III·

Valeant Pharmaceuticals

Acnefree 24 Hour Clearing System Containing 1-count 4 FL OZ (118 ML) Oil-free Purifying…

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label…

Nationwide (US)Cosmetics
Class III·

Valeant Pharmaceuticals

Acnefree 24 Hour Severe Acne Clearing System Containing 1-count 4 FL OZ (118 ML) Bottle…

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label…

Nationwide (US)Cosmetics

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.