AcneFree 24 Hour Clearing System containing 1-count 4 fl oz — Class III drug recall D-042-2013
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-042-2013 |
|---|---|
| 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 | 1,097,846 cartons |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00788521120086 |
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 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-042-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.