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FDAJuly 17, 2025drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

dermarite

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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