Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-043-2013·Announced 2012-11-14

Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System

Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is 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 the rubric indicates is typically a score of 1 or 2. The presence of mislabeling alongside the subpotent ingredient supports a score of 2 (Moderate) rather than 1 (Low).

Plain-English summary

Valeant Pharmaceuticals is recalling 477,107 cartons of the AcneFree 24 Hour Severe Acne Clearing System. The recalled product contains an Antibacterial Cleansing Wash, Corrective Toner, Maximum Strength Repair Lotion, and Retinol Renewal Complex. The recall covers all lots with expiration dates between 10/10/12 and 10/10/14 for UPC 7 88521 12900 3.

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. The product was distributed nationwide.

Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for instructions.

The recalled product

Product: AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair…
Manufacturer: Valeant Pharmaceuticals
Category: Drug — Topical OTC
Hazard: subpotent-drug
mis-labeling
Affected units: 477,107

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 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
Moderate
Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser
FDA (Drugs) · 2012-11-14

Same hazard · subpotent drug