Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-044-2013·Announced 2012-11-14

Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser

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

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 issues involve subpotency and labeling errors, fitting the criteria for moderate severity.

Plain-English summary

Valeant Pharmaceuticals is recalling 145,650 bottles of AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottles. The product is distributed by University Medical Pharmaceuticals Corp. in Irvine, CA, and was sold nationwide. The recall covers all lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8.

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.

Consumers should check their products for the specific UPC and expiration date range listed above. If the product matches the description, consumers should stop using it and contact the recalling firm for further instructions.

The recalled product

Product: AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
Manufacturer: Valeant Pharmaceuticals
Category: Drug — Topical OTC
Hazard: subpotent-drug
mis-labeling
Affected units: 145,650

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 →

Same manufacturer · Valeant Pharmaceuticals

See all →

Low
Valeant Recalls Subpotent AcneFree 3-in-1 Acne Night Repair Foam
FDA (Drugs) · 2012-11-14
Moderate
Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System
FDA (Drugs) · 2012-11-14
Moderate
Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide
FDA (Drugs) · 2012-11-14
Moderate
Valeant Recalls Subpotent AcneFree Acne Pore Cleanser
FDA (Drugs) · 2012-11-14
Low
FDA Recalls Subpotent AcneFree Benzoyl Peroxide Cleanser
FDA (Drugs) · 2012-11-14

Same hazard · subpotent drug