CLASS III Drug recall · Reported 5 Aug 2020 · FDA Enforcement Report
Skin Medica Acne System, Contains: Purifying Foaming Wash recalled
Allergan is recalling Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), distributed nationwide in the US. The recall was initiated on 6 Jul 2020 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-1410-2020
- FDA event ID
- 85924
- Recalling firm
- Allergan, Irvine, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Jul 2020
- FDA classified
- 27 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 6 Jul 2020 | Recall initiated by company | |
| 27 Jul 2020 | Classified by FDA | +21 days |
| 5 Aug 2020 | 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
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Which lots are affected?
Lot #: 090645A, 090645B, Exp. Date 07/31/2020; 090645C, Exp. Date 08/31/2020; Lot #: 090757A, Exp. Date 02/29/2020; Lot # 093199A, 093199B, 093199C, 093199D, Exp. Date 12/31/2020; Lot #: 096375A, 096375B, Exp. Date 06/30/2021; Lot #: 097455A, 097612A, Exp. Date 04/30/2021
Where was it sold?
Nationwide within the United States
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 85924| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) recalled | Allergan | Potency & Assay | Nationwide |
More recalls from Allergan
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Refresh Contacts¿ Contact Lens Comfort Drops Sterile recalled | Allergan | Other | MO |
| Drug | CLASS II | Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile recalledRefresh Relieva Preservative Free | Allergan | Other | Nationwide |
| Drug | CLASS III | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) recalled | Allergan | Potency & Assay | Nationwide |
| Device | CLASS II | XEN Gel Stent recalled by Allergan | Allergan | Sterility | Nationwide |
| Device | CLASS I | Ritz Princess, Biocell, Intrashiel recalled by Allergan | Allergan | Foreign Material | Nationwide |