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.
What this means for you
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 Lot
- Manufacturer
- Valeant Pharmaceuticals
- Category
- Drug — Topical OTC
- 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 →Related recalls
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