CLASS III Drug recall · Reported 14 Nov 2012 · FDA Enforcement Report
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v) recalled
Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v), 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-046-2013
- 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
- Potency & Assay
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 salicyclic acid active ingredient.
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
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Which lots are affected?
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 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 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
7 other products · FDA event 63488More 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 2.5% 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 2.5% w/v) recalled | Valeant Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS III | AcneFree 24 Hour Clearing System recalled by Valeant Pharmaceuticals | Valeant Pharmaceuticals | Labeling Errors | Nationwide |