Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide
Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.
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 2/5 (Moderate).
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 is defined as unlikely to cause adverse health consequences. The hazard involves a subpotent ingredient and labeling errors, fitting the criteria for a moderate severity score.
Plain-English summary
Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tubes. The product is distributed by University Medical Pharmaceuticals Corp. in Irvine, CA, and was sold nationwide.
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 to the label.
The recall includes all lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7. Consumers should stop using the product and return it to the place of purchase.
The recalled product
- Product
- AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
- Manufacturer
- Valeant Pharmaceuticals
- Category
- Drug — Topical OTC
- Affected units
- 619,029
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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