FDA Issues Class I Recall for Multiple DermaRite Antiseptic and Analgesic Products Due to Dangerous Microbial Contamination

The US Food and Drug Administration (FDA) has issued a Class I recall for several topical products distributed by DermaRite Industries LLC, including DermaKleen Antiseptic Lotion Soap, DermaSarra External Analgesic, KleenFoam Antimicrobial Foam Soap, and PeriGiene Health Care Antiseptic. These products were found to be contaminated with Burkholderia cepacia, a bacteria known to pose serious risks, especially to immunocompromised individuals. The recall includes tens of thousands of units distributed nationwide and covers a wide range of expiration dates, with some batches valid through January 2027. The contamination affects both large-volume bag-in-box dispensers and personal-use bottles.

The recalling firm, DermaRite Industries LLC, located in North Bergen, New Jersey, initiated the recall on July 17, 2025, with FDA classification finalized as Class I on September 2, 2025. A Class I recall indicates the most serious type of risk, where use of the product could lead to serious health consequences or death, particularly in healthcare settings where sterile or near-sterile products are essential. The affected products include:

• DermaKleen (Chloroxylenol 0.2%), NDCs 61924-092-27 and 61924-092-34
• DermaSarra (Camphor 0.5%), NDC 61924-189-08
• KleenFoam (Chloroxylenol 0.5%), NDC 61924-093-34
• PeriGiene (Chloroxylenol 0.5%), NDC 61924-198-08

These recalled products are marketed as healthcare antiseptics or topical analgesics, often used in clinical settings for hand hygiene, skin cleansing, or pain relief. The presence of Burkholderia cepacia, a pathogen that can survive in aqueous solutions, poses significant danger to vulnerable patients, including those with chronic respiratory conditions, open wounds, or weakened immune systems.