FDA Drug recall D-045-2013
AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irv…
- FDA Drug
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irv… 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-045-2013 |
| 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 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
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 | 788521120307 |
|---|---|
| code_info | All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Valeant Pharmaceuticals
- AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceutic…
FDA Drug · Class III · 2012-11-14 · Valeant Pharmaceuticals - AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp.,…
FDA Drug · Class III · 2012-11-14 · Valeant Pharmaceuticals - AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v)
FDA Drug · Class III · 2012-11-14 · Valeant Pharmaceuticals - AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine,…
FDA Drug · Class III · 2012-11-14 · Valeant Pharmaceuticals - 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 · 2012-11-14 · Valeant Pharmaceuticals
All Valeant Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-045-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.