CLASS III Drug recall · Reported 14 Nov 2012 · FDA Enforcement Report
AcneFree 24 Hour Clearing System recalled by Valeant Pharmaceuticals
Valeant Pharmaceuticals is recalling AcneFree 24 Hour Clearing System containing Oil-Free Purifying Cleanser (benzoyl peroxide, distributed nationwide in the US. The recall was initiated on 15 Oct 2012 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-042-2013
- FDA event ID
- 63488
- Recalling firm
- Valeant Pharmaceuticals, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Oct 2012
- FDA classified
- 6 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Oct 2012 | Recall initiated by company | |
| 6 Nov 2012 | Classified by FDA | +22 days |
| 14 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product as listed by the FDA
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
Where it was distributed
Nationwide
Questions about this recall
Is AcneFree 24 Hour Clearing System containing Oil-Free Purifying Cleanser (benzoyl peroxide recalled?
Yes. Valeant Pharmaceuticals recalled AcneFree 24 Hour Clearing System containing Oil-Free Purifying Cleanser (benzoyl peroxide on 15 Oct 2012. The recall is Class III and its status is Terminated. Recall number D-042-2013.
Why was it recalled?
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Which lots are affected?
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
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 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.
More recalls from Valeant Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | AcneFree-1 Acne Night Repair Foam recalled by Valeant Pharmaceuticals | Valeant Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | AcneFree Acne Pore Cleanser (benzoyl peroxide 5% w/v) canister recalled | Valeant Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | AcneFree 24 Hour Severe Acne Clearing System recalled | Valeant Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 5% w/v) recalled | Valeant Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v) tube recalled | Valeant Pharmaceuticals | Labeling Errors | Nationwide |