FDA Recall D-0612-2025

DermaRite Industries, LLC · North Bergen, NJ

Class I — life-threatening Ongoing 301 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: 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.

Quantity: 6,973 cartridges

Reason for recall

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

Recall record

Recall number: D-0612-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA
Recall initiated: 2025-07-17
Classified by FDA Center: 2025-09-02
FDA published: 2025-09-10
Recalling firm: DermaRite Industries, LLC
Firm location: North Bergen, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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