FDA

DermaRite recalls hygiene products due to Burkholderia cepacia contamination

August 13, 2025

DermaRite Industries, LLC, is voluntarily recalling specific lots of four over-the-counter products—DermaKleen antiseptic lotion soap, DermaSarra external analgesic, KleenFoam antimicrobial foam soap, and PeriGiene antiseptic cleanser—due to microbial contamination identified as Burkholderia cepacia complex. These products were distributed nationwide in the U.S. and Puerto Rico. The contamination may lead to serious and potentially life-threatening infections, especially in immunocompromised individuals or those caring for them. In healthy individuals with minor skin lesions, use may result in localized infections, while immunocompromised users are at risk for bloodstream infections and sepsis. No adverse events have been reported to date.

DermaRite has notified distributors and customers to examine inventory and destroy affected products per facility protocols. Consumers with questions can contact the company directly, and those experiencing adverse effects should consult a healthcare provider and report incidents to the FDA’s MedWatch program. This recall is being conducted with FDA knowledge.

Source:

(2025, August 9). FDA. DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and