DermaKleen recalled over sterility concerns

Recall date

July 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DermaRite Industries, LLC recalls DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.)…

Recall number

D-0610-2025

FDA classification

Class I

Brand / firm

DermaRite Industries, LLC

Sold / distributed

Nationwide within the USA

Why it was recalled

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.