# FDA recall D-045-2013

> **Valeant Pharmaceuticals** · Class III · drug recall initiated 2012-10-15.

## Product

AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, AFCS-0402, UPC 7 88521 12030 7.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-045-2013
- **Recalling firm:** Valeant Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-10-15
- **Report date:** 2012-11-14
- **Termination date:** 2013-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-045-2013

## Citation

> AI Analytics. FDA recall D-045-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-045-2013. Source: US FDA. Licensed CC0.

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