The Recall Desk
LowFDA (Drugs)·D-0673-2017·Announced 2017-04-26

Valeant Recalls CLENZIderm M.D. Acne Treatment Kits Due to Discoloration

Valeant Pharmaceuticals is voluntarily recalling 5,647 units of CLENZIderm M.D. Acne Treatment Systems nationwide due to product discoloration.

What this means for you

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 stated reason is discoloration, which is a cosmetic defect.

Plain-English summary

Valeant Pharmaceuticals North America LLC is voluntarily recalling 5,647 units of the CLENZIderm M.D. Acne Treatment System. The recall was initiated on March 20, 2017, and is classified as Class III by the FDA. The affected product is a kit containing three bottles: Therapeutic Lotion (benzoyl peroxide 5%), Daily Care Foaming Cleanser (Salicylic Acid 2%), and Salicylic Acid 2% Acne Treatment.

The reason for the recall is discoloration. The affected lots are: a) 15I1234 (Exp. 09/18), b) 15E1221 (Exp. 09/18), and c) 15G1235 and 15I1236 (Exp. 09/18). The product was distributed nationwide. The recall was terminated on June 14, 2019.

Consumers with these specific lot numbers should stop using the product and contact the manufacturer or their point of purchase for instructions. The FDA classifies this as a Class III recall, which means the product is not likely to cause adverse health consequences.

The recalled product

Product
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals No
Affected units
5,647

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #: a) 15I1234
  • Exp. 09/18
  • b) 15E1221
  • c) 15G1235 and 15I1236
  • Exp. 09/18.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Valeant Pharmaceuticals North America LLC 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 2 products in this recall →

Same manufacturer · Valeant Pharmaceuticals North America LLC

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