CLASS III Drug recall · Reported 26 Apr 2017 · FDA Enforcement Report
CLENZIderm M.D. Acne Treatment System recalled
Valeant Pharmaceuticals North America is recalling CLENZIderm M.D. Acne Treatment System, kit has a) Therapeutic Lotion (benzoyl peroxide 5%, distributed nationwide in the US. The recall was initiated on 20 Mar 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0673-2017
- FDA event ID
- 76743
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Mar 2017
- FDA classified
- 17 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Mar 2017 | Recall initiated by company | |
| 17 Apr 2017 | Classified by FDA | +28 days |
| 26 Apr 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration.
Product as listed by the FDA
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 North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
Discoloration.
Which lots are affected?
Lot #: a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76743This product is part of a recall event; the main page for the event is CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne recalled | Valeant Pharmaceuticals North America | Other | Nationwide |
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl CD capsules, 360 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |