FDA Drug recall D-042-2013
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,…
- FDA Drug
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of 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,… by Valeant Pharmaceuticals, citing 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 e….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-042-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-15 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| upc | 788521120086 |
|---|---|
| code_info | All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-042-2013%22
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