Urgent Recall Issued for Contaminated Hand Soaps Linked to Life-Threatening Sepsis

DermaRite Industries LLC has voluntarily recalled over a dozen hand soap and sanitizer products sold nationwide in the United States and Puerto Rico after detecting contamination with Burkholderia cepacia, a bacterium that can cause serious infections, including life-threatening sepsis, especially in immunocompromised individuals. The recall was announced on August 8, 2025, with no adverse reactions reported as of that date, according to the company.

"In healthy individuals with minor skin lesions, the use of the product will more likely result in local infections, whereas in immunocompromised individuals, the infection is more likely to spread into the bloodstream, leading to life-threatening sepsis," stated DermaRite in their news release.

The bacterium, found in water and soil, is resistant to many antimicrobials and can spread person-to-person, leading to symptoms like fever, fatigue, coughing up blood, or severe pneumonia, per the Centers for Disease Control and Prevention (CDC).

On August 8, 2025, DermaRite Industries LLC, based in North Bergen, New Jersey, initiated a voluntary recall following testing that revealed Burkholderia cepacia contamination in some products. The affected items include various over-the-counter lotion soaps, antiseptic cleansers, and foam soaps distributed to retailers, healthcare facilities, and consumers, often used in hospitals, nursing homes, and homes for wound care.The company emphasized that while the risk affects everyone, those with weakened immune systems—such as people with cystic fibrosis, lung disease, cancer, or recent surgeries—are most vulnerable. The U.S. Food and Drug Administration (FDA) has urged users experiencing side effects to contact healthcare providers and report issues via its MedWatch program. The FDA noted that the agency does not endorse DermaRite but shares recall announcements for public safety.

Sepsis is a life-threatening medical emergency where the body's extreme response to an infection damages its own tissues and organs. It can arise from bacterial infections like Burkholderia cepacia entering the bloodstream, leading to symptoms such as rapid breathing, confusion, and organ failure. According to health experts, early treatment is critical, but antimicrobial-resistant bacteria like B. cepacia make it harder to manage, potentially resulting in severe outcomes or death, especially in immunocompromised patients. The CDC highlights that B. cepacia poses little threat to healthy individuals but is particularly dangerous for those with chronic conditions.

A recall is a voluntary or mandatory action by a manufacturer to remove potentially unsafe products from the market to protect public health. In this case, it's voluntary, meaning DermaRite initiated it after discovering the contamination. Recalls are classified by risk level; this one is urgent due to the potential for serious infections. The FDA oversees such actions, ensuring companies notify distributors, customers, and the public, often providing instructions for returns or disposal. DermaRite has not disclosed how the contamination occurred, but the FDA is investigating the extent of the issue.

The following is the list of products recalled by DermaRite Industries LLC, as provided by the U.S. Food and Drug Administration (FDA). These products, distributed nationwide in the United States and Puerto Rico, include specific lots of antiseptic soaps and an analgesic cream, with expiration dates ranging from July 2025 to February 2027. Consumers can identify affected items by checking brand names, reorder numbers, and lot numbers printed on the product labels or packaging. The FDA has made a comprehensive list of affected lot and reorder numbers available on its website to assist with identification. DermaRite urges immediate discontinuation of these products to prevent potential infections, including life-threatening sepsis, and advises safe disposal following facility protocols or returning items for a full refund.

Consumers should immediately stop using the affected products and check labels against the recall list. DermaRite advises destroying the products using safety protocols like autoclaving or chemical treatment or returning them to the place of purchase for a full refund. For questions, email voluntary.action@dermarite.com or call 973-569-9000 ext. 104, Monday through Friday from 9 a.m. to 5 p.m. EST. If you've experienced symptoms like fever, fatigue, breathing problems, or skin infections after use, consult a physician promptly, mentioning the soap recall as Burkholderia infections require specific antibiotics. Report any adverse events to the FDA's MedWatch program online. The company has notified distributors to examine and destroy inventory, emphasizing safe disposal per facility protocols to prevent further exposure. For added safety, consumers can switch to alternative antiseptics like chlorhexidine-based products while avoiding recalled items.

(Rh/Eth/MKB/MSM)