DermaKleen Antiseptic Soap (DermaRite Industries) – Microbial Contamination (2025)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
DermaRite Industries, LLC
Lot Codes / Batch Numbers
Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025, 30670A, 30682A, Exp. Date 8/2025, 40025A, Exp. Date 1/2026, 40375A, Exp. Date 4/2026, 40427A, 40436A, Exp. Date 5/2026, 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025, 30628A, 30657A, Exp. Date 8/2025, 30741A, Exp. Date 7/2025, 30871A, Exp. Date 10/2025, 40002A, Exp. Date 12/2025, 40012A, Exp. Date 1/2026, 40301A, Exp. Date 3/2026, 40789 A, Exp. Date 9/2026, 50068B, Exp. Date 1/2027, 50144A, 50149A, Exp. Date 2/2027.
Products Sold
Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
DermaRite Industries, LLC is recalling DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 8 due to Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.