FDA Recalls Subpotent AcneFree Benzoyl Peroxide Cleanser
Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves subpotency and labeling errors rather than acute physical danger.
Plain-English summary
Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canisters. The recall involves 10,434 canisters distributed nationwide. The affected products are identified by UPC 7 88521 13550 9 and have expiration dates between 10/10/12 and 10/10/14.
The FDA classified this as a Class III recall 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 adds inactive ingredients.
Consumers should stop using the product and return it to the place of purchase for a refund or follow instructions from the recalling firm.
The recalled product
- Product
- AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
- Manufacturer
- Valeant Pharmaceuticals
- Category
- Drug — Topical OTC
- Affected units
- 10,434
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 →Related recalls
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