Agency classClass IIIOur severity:Low FDA (Drugs)·D-042-2013·Announced 2012-11-14

Valeant Recalls Subpotent AcneFree 24 Hour Clearing System

Valeant Pharmaceuticals is recalling AcneFree 24 Hour Clearing System cartons because the benzoyl peroxide active ingredient is subpotent and the labels contain 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 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 by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor labeling or potency issues without reported harm.

Plain-English summary

Valeant Pharmaceuticals is recalling 1,097,846 cartons of AcneFree 24 Hour Clearing System. The product is distributed nationwide and includes an Oil-Free Purifying Cleanser, Renewing Toner, and Repair Lotion. The recall covers all lots with expiration dates between October 10, 2012, and October 10, 2014, identified by UPC 7 88521 12008 6.

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 agency determined that this violation is not likely to cause adverse health consequences.

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

The recalled product

Product: AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per…
Manufacturer: Valeant Pharmaceuticals
Category: Drug — Topical Acne Treatment
Hazard: subpotent-drug
mis-labeling
Affected units: 1,097,846

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