The Recall Desk
ModerateFDA (Drugs)·D-049-2013·Announced 2012-11-14

Valeant Recalls Subpotent AcneFree Acne Pore Cleanser

Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves a subpotent active ingredient and labeling errors, which aligns with the 'Moderate' criteria for minor labeling errors or low-risk issues.

Plain-English summary

Valeant Pharmaceuticals is recalling 115,785 canisters of AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g). The product is distributed nationwide by University Medical Pharmaceuticals Corp. The recall covers all lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2.

The recall was initiated because the product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, the product is mislabeled because the label either omits or erroneously added inactive ingredients.

Consumers with this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
Affected units
115,785

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Valeant Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →