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.
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 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…
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Topical Acne Treatment
- Hazard
- 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 →Related recalls
Same manufacturer · Valeant Pharmaceuticals North America LLC
See all →- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- LowValeant Recalls Diltiazem HCl Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateMedicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling
FDA (Drugs) · 2013-08-28
- LowValeant Recalls Subpotent AcneFree 24 Hour Clearing System
FDA (Drugs) · 2012-11-14
- ModerateValeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System
FDA (Drugs) · 2012-11-14
- ModerateValeant Recalls Subpotent AcneFree Acne Pore Cleanser
FDA (Drugs) · 2012-11-14
- ModerateValeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser
FDA (Drugs) · 2012-11-14
- LowValeant Recalls Subpotent AcneFree 3-in-1 Acne Night Repair Foam
FDA (Drugs) · 2012-11-14