Class IOngoing

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packag… recall

FDA recall D-0610-2025 · initiated Jul 17, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

Product: 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.
Recalling company: DermaRite Industries, LLC
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the USA
Initiated: Jul 17, 2025
FDA report date: Sep 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0610-2025 ↗

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