AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl… — Class III drug recall D-043-2013
Terminated recall by Valeant Pharmaceuticals, reported 2012-11-14, distributed nationwide. Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ing
| Recall number | D-043-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals, Bridgewater, NJ, United States |
| Recall initiated | 2012-10-15 |
| Classified | 2012-11-06 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 477,107 cartons |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00788521129003 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.