Valeant Pharmaceuticals: 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.; Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.; Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredien

Agency Publication Date: November 7, 2012

Affected Products

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.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6

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.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3

Product: AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8

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.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7

Product: AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6

Product: AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6

Product: AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9

Product: AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63488

Status: Resolved

Manufacturer: Valeant Pharmaceuticals

Manufactured In: United States

Units Affected: 8 products (1,097,846 cartons; 477,107 cartons; 145,650 bottles; 619,029 tubes; 71,369 jars; 81,319 canisters; 10,434 canisters; 115,785 canisters)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products