FDA Drug recall D-043-2013
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5%…
- FDA Drug
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5%… 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-043-2013 |
| 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 Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.
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 | 788521129003 |
|---|---|
| code_info | All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3 |
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-043-2013%22
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