CLASS II Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
CLENZIderm M.D recalled by Medicis Pharmaceutical
Medicis Pharmaceutical is recalling CLENZIderm M.D, distributed nationwide in the US. The recall was initiated on 1 May 2013 and the FDA has classified it as Class II.
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-916-2013
- FDA event ID
- 65559
- Recalling firm
- Medicis Pharmaceutical, Scottsdale, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2013
- FDA classified
- 22 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 1 May 2013 | Recall initiated by company | |
| 22 Aug 2013 | Classified by FDA | +113 days |
| 28 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Product as listed by the FDA
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.
Where it was distributed
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
Questions about this recall
Is CLENZIderm M.D recalled?
Yes. Medicis Pharmaceutical recalled CLENZIderm M.D on 1 May 2013. The recall is Class II and its status is Terminated. Recall number D-916-2013.
Why was it recalled?
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Which lots are affected?
Lot #11L1074, NDC 62032-110; Expanded 8/29/2013 to include Lot 11J1075, NDC 62032-511, Exp. 10/14.
Where was it sold?
Nationwide, Great Britain, Mexico, Russia and The Ukraine.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.