DermaRite Industries, a North Bergen, New Jersey-based manufacturer of over-the-counter healthcare products, has issued a voluntary nationwide recall of multiple soap and skincare products after testing revealed contamination with Burkholderia cepacia complex (Bcc), a bacterium that can cause severe infections. The affected items were distributed across the United States and Puerto Rico, with some sold through major retailers including Walmart and Amazon.
The recall, announced on August 8 and detailed by the U.S. Food and Drug Administration (FDA) on August 9, covers specific lots of four products: DermaKleen antiseptic lotion soap with vitamin E, DermaSarra external analgesic cream, KleenFoam antimicrobial foam soap, and PeriGiene antiseptic perineal cleanser. The products are commonly used in healthcare settings, including hospitals and nursing homes, and may also be used by individuals at home.
According to the Centers for Disease Control and Prevention, Bcc is a group of bacteria found in soil and water. While it generally poses little risk to healthy individuals, it can cause serious respiratory infections and, in severe cases, life-threatening sepsis in people with weakened immune systems, such as those with cystic fibrosis or chronic lung disease. The FDA warned that in healthy individuals with minor skin cuts, the bacteria may cause localized infections, but in immunocompromised individuals, it can enter the bloodstream, leading to sepsis and potentially septic shock.
Bacteria poses severe risk for immunocompromised individuals
The recalled products include DermaKleen in 800ml and 1000ml refill bags with expiration dates between July 2025 and February 2027, DermaSarra in 7.5oz tubes expiring February 2026, KleenFoam in 1000ml refill bags expiring between August 2025 and January 2027, and PeriGiene in 7.5oz bottles expiring between November 2025 and January 2027. A full list of lot numbers is available through the FDA. DermaRite said it has not received any reports of adverse reactions connected to the recalled products.
The company has instructed its distributors and customers via email to immediately review their inventories and destroy all affected items in accordance with their facility procedures. Consumers in possession of these products are advised to stop using them immediately. Those who have used the recalled items and experienced symptoms such as fever, fatigue, or signs of infection should contact a healthcare provider.
FDA urges reporting of adverse reactions to MedWatch
The FDA advises that adverse reactions or quality concerns be reported to its MedWatch Adverse Event Reporting program, either online or via mail or fax. The company has provided a contact for questions regarding the recall: Mary Goldberg at 1-973-569-9000 ext. 104, Monday through Friday, from 9 a.m. to 5 p.m. Eastern Time, or by email.
Consumers may also return the products to the place of purchase for a full refund. DermaRite’s recall underscores the heightened risk posed by contaminated hygiene products to vulnerable populations and the importance of immediate action when contamination is detected. The FDA and the company continue to monitor the situation, with the recall aimed at preventing potential infections before any adverse events occur. – By Content Syndication Services.