Antimicrobial foam soap recalled over contamination with Burkholderia cepacia
DermaRite KleenFoam Antimicrobial Foam Soap with Aloe Vera is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 6,973 cartridges are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this Burkholderia cepacia contamination as Class I.
Plain-English summary
KleenFoam Antimicrobial Foam Soap with Aloe Vera, containing chloroxylenol 0.5%, in 34 fl oz (1000 mL) cartridges from DermaRite Industries LLC of North Bergen, New Jersey, NDC 61924-093-34, is being recalled. Affected lots include 30705A expiring 8/2025, 30771A expiring 9/2025, 30920A expiring 10/2025 and 40016A expiring 1/2026. The recall covers 6,973 cartridges distributed nationwide.
The recall was issued for microbial contamination of a non-sterile drug product: the products were found to be contaminated with the bacteria Burkholderia cepacia. The FDA classified the action as Class I, its most serious category.
Healthcare facilities and consumers holding these lots should stop using the product and follow the manufacturer's instructions for return or disposal.
The recalled product
- Product
- KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Antiseptic
- Affected units
- 6,973
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 30705A
- Exp. Date 8/2025
- 30771A
- Exp. Date 9/2025
- 30920A
- Exp. Date 10/2025
- 40016A
- Exp. Date 1/2026
- 40303A
- Exp. Date 4/2026
- 40428A
- Exp. Date 5/2026
- 40505A
- Exp. Date 6/2026
- 41053C
- 41053A
- 41053B
- Exp. Date 12/2026
- 50017A
- Exp. Date 1/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by DermaRite Industries, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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