:max_bytes(150000):strip_icc()/Copyofrecall-template-purple2-ee1a123e4e9247dc8a35ff83d4641d59.png?w=1920&resize=1920,1267&ssl=1 "Critical Alert: Skincare Recall Expands Due to Infection Risk")
A significant product safety issue has emerged with the expanded nationwide recall of over 30 skincare and hygiene products manufactured by DermaRite Industries, LLC. Triggered by potential contamination with Burkholderia cepacia complex (Bcc) bacteria, this recall, overseen by the U.S. Food and Drug Administration (FDA), poses a serious infection risk, especially for immunocompromised individuals. Consumers and healthcare facilities are strongly advised to immediately discontinue use and dispose of the affected items to mitigate potential health hazards.
Understanding the Recall
Who is Involved?
The primary entities involved in this recall are DermaRite Industries, LLC, the manufacturer of the affected skincare and hygiene products, and the U.S. Food and Drug Administration (FDA), which is providing oversight and public alerts. According to the FDA, the recall impacts consumers across the United States and Puerto Rico, particularly those with weakened immune systems, chronic lung conditions such as cystic fibrosis, or existing skin lesions. Healthcare facilities, including nursing homes and hospitals, are also significantly affected due to the widespread use of these products in patient care.
What Products Are Recalled?
The expanded recall includes a wide array of over-the-counter skincare and hygiene products manufactured by DermaRite Industries. The recall was expanded on August 27, 2025, to include additional products and lots. Some of the recalled products include, but are not limited to: 3-N-1, 4-N-1, Clean-N-Free, DermaCerin, DemaDaily, DermaFungal, DermaKleen, DemaKlenz, DermaMed, DermaRain, DermaSarra, DermaSyn, DermaVantage, DermaVera, Gel Rite, Hand E Foam, KleenFoam, Lantiseptic, PeriGiene, PeriGuard, Renew Dimethicone, and Renew Periprotect, according to DermaRite Industries. These products encompass various forms, including body washes, shampoos, perineal cleansers, moisturizing creams, antifungal treatments, and hand sanitizers.
When and Where Did This Occur?
The initial recall was issued on July 16, 2025, and was subsequently expanded on August 27, 2025. News outlets widely reported the expanded recall in early September 2025, around September 10-12, 2025. The recalled products were distributed nationwide across the United States and Puerto Rico. They were available for purchase through DermaRite’s official website, Amazon, and major retailers like Walmart and Sam’s Club. The FDA notes that these products are also commonly used in healthcare settings, increasing the risk to vulnerable patients.
The Infection Risk
Why the Recall Was Initiated
The recall was prompted by the potential for microbial contamination with Burkholderia cepacia complex (Bcc). According to a report by Yahoo News Canada, Bcc is a group of bacteria commonly found in soil and water. While Bcc poses a minimal risk to healthy individuals, it can lead to severe and life-threatening infections in those with compromised immune systems or pre-existing lung conditions, such as cystic fibrosis. For healthy individuals with minor skin lesions, the use of contaminated products may result in localized infections. However, immunocompromised individuals face a higher risk of the infection spreading into the bloodstream, potentially causing sepsis, a life-threatening medical emergency.
The Dangers of Burkholderia cepacia complex (Bcc)
A significant concern with Bcc infections is the bacteria’s resistance to many antibiotics, making treatment challenging. The FDA emphasizes that individuals with cystic fibrosis are particularly vulnerable, as Bcc infections can exacerbate their condition and lead to serious complications. Symptoms of a Bcc infection may include fever, fatigue, redness, or swelling at the site of infection. It is crucial for anyone experiencing these symptoms after using the recalled products to seek immediate medical attention. Early diagnosis and treatment are essential to managing Bcc infections effectively.
Impact and Actions Taken
Immediate Actions for Consumers and Facilities
DermaRite has issued instructions for its distributors and customers to immediately inspect their inventory and destroy all affected products according to their facility’s established procedures. Consumers who have used any of the recalled products and experienced adverse reactions, such as fever, fatigue, redness, or swelling, should contact their physician or healthcare provider without delay. According to Good Housekeeping, as of earlier reports, DermaRite had not received any reports of adverse events directly related to this specific recall. However, vigilance and prompt action are crucial to prevent potential health complications.
Contact Information for Inquiries
For questions regarding the recall, consumers can contact Sedgwick at 888-943-5190 (Monday-Friday, 8 a.m. to 5 p.m. EST) or email dermarite5186@sedgwick.com. The FDA also provides resources and information on its website to assist consumers and healthcare professionals in identifying and managing recalled products. Staying informed and taking swift action are essential steps in protecting public health and safety.
Conclusion
The expanded recall of DermaRite skincare and hygiene products due to potential Bcc contamination underscores the critical importance of product safety and regulatory oversight. Consumers, especially those with compromised immune systems, should remain vigilant and adhere to the recall instructions to mitigate potential health risks. By staying informed and taking prompt action, individuals and healthcare facilities can effectively manage the situation and safeguard public health.
