Agency classClass IIIOur severity:Low FDA (Drugs)·D-047-2013·Announced 2012-11-14

Valeant Recalls Subpotent AcneFree 3-in-1 Acne Night Repair Foam

Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam because the salicylic acid ingredient is subpotent and the label is inaccurate.

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. The issues are subpotency of a single ingredient and labeling errors, which align with the 'Low' severity criteria for minor labeling errors or low-risk issues.

Plain-English summary

Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz canisters. The recall involves 81,319 canisters distributed nationwide. The affected products are identified by UPC 7 88521 13548 6 and have expiration dates between 10/10/12 and 10/10/14.

The FDA classified this as a Class III recall because the product was found to be subpotent for the salicylic acid ingredient. Additionally, the product is mislabeled because the label either omits or erroneously adds inactive ingredients.

Consumers should stop using the product and return it to the place of purchase for a refund. The recall is being conducted by Valeant Pharmaceuticals, with distribution by University Medical Pharmaceuticals Corp.

The recalled product

Product: AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.
Manufacturer: Valeant Pharmaceuticals
Category: Drug — Topical Acne Treatment
Hazard: subpotent-drug
mis-labeling
Affected units: 81,319

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

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