DermaRite Expands Recall to More Skincare Products Over Hand Soap Concerns

Expanded Recall: DermaRite Products Pulled From Shelves Nationwide Over Contamination Concerns

September 11, 2025

North Bergen, New Jersey – DermaRite industries is voluntarily expanding a product recall initiated in August, now encompassing more than 30 items. The expansion stems from potential microbial contamination identified as burkholderia cepacia complex, prompting the company to act “out of an abundance of caution.” The recall affects a wide range of personal care products, including hand soaps, lotions, shampoos, and more.

Health Officials state that B. cepacia can lead to severe, and potentially life-threatening infections, notably in individuals with compromised immune systems or those caring for them. The infection poses a risk of spreading to the bloodstream and causing sepsis, a dangerous medical condition.

Which DermaRite products Are Affected?

The expanded recall includes a extensive list of products, covering various personal hygiene needs.Consumers are urged to check their homes for the following:

Product Category	Product Name
Cleansers	3-N-1,4-N-1,Clean-N-Free,DermaRain
Skin Protectants	Dermacerin,Lantiseptic,Renew Dimethicone,Renew Periprotect,Renew Skin Repair,UltraSure
Moisturizers	Daydaily,Lubristilk,Dermas,Dermavera
Antiseptics	Dermakleen,Demaklenz,PeriGiene
Other	DermaMed,DermaSarra,DermaSyn,Gel Rite,Hand E Foam,KleenFoam,PeriFresh,Renew Hair and Body Wash,San-E-Foam,TotalBath,TotalFoam,WhirlBath,DermaFungal

Did You Know? Burkholderia cepacia is a common bacterium found in soil and water,but it can become problematic in healthcare settings or when introduced to vulnerable individuals through contaminated products.

The company initially started the recall concentrating on hand soaps,but subsequently broadened the scope after further examination.

Where Where These Products Sold?

The recalled products were distributed across the United States and Puerto Rico. DermaRite Industries has instructed its distributors and customers to remove all affected items from inventory and destroy them following established protocols. While the Food and Drug Management (FDA) has not specified which retailers carried the products, consumers are advised to check their own stock immediately.

Customers with questions or concerns regarding the recall can contact Sedgwick at 888-943-5190 or via email at [email protected], Monday through Friday, between 8:00 AM and 5:00 PM Eastern Time.

Understanding Burkholderia Cepacia

According to the Centers for Disease Control and Prevention (CDC), B. cepacia generally poses a low risk to healthy individuals. Though, it can cause serious infections in those with weakened immune systems, particularly individuals with cystic fibrosis. The CDC notes that infections are often linked to contaminated medical equipment or healthcare environments.Further details about B. cepacia is available on the CDC website.

As of this report, neither DermaRite Industries nor the FDA has received reports of adverse reactions linked to the recalled products.

Pro Tip: always check the FDA website or subscribe to recall alerts for the latest information on product safety.

Product Recall Best Practices

Product recalls are a crucial aspect of consumer safety. Here are some best practices to follow:

• Stay Informed: Regularly check for recall announcements from the FDA and other regulatory agencies.
• Register Products: when possible, register your products with the manufacturer to receive direct notification of recalls.
• Proper Disposal: Follow the instructions provided by the manufacturer or regulatory agency for proper disposal of recalled items.

Frequently Asked Questions About the DermaRite Recall

Do you have any of the recalled DermaRite products in your home? What steps will you take to ensure your family’s safety considering this recall?

What specific quality control failures led to the microbial contamination of DermaRite products?

Expanding Recall: What You Need to Know

DermaRite Industries, LLC has significantly expanded its voluntary recall of skincare products initially triggered by concerns over microbial contamination in its hand soaps. The expansion, announced September 11, 2025, now encompasses a wider range of lotions, creams, and washes manufactured at the company’s facility.This recall impacts consumers across the United States and raises significant questions about product safety and hygiene standards in the skincare industry. The initial recall, issued in late August, focused specifically on several hand soap varieties.

Products Affected by the DermaRite Recall

The expanded recall now includes products marketed under various brand names, often used in healthcare settings, long-term care facilities, and by individual consumers. Key product categories affected include:

* Hand Soaps: All previously recalled hand soap varieties remain under the recall.

* Lotions & Moisturizers: A significant number of lotion and moisturizer formulations are now included,spanning different sizes and packaging.

* Body Washes: Certain body wash products manufactured at the affected facility are also subject to the recall.

* Skin Cleansers: Specialized skin cleansers, notably those used for sensitive skin or wound care, are included.

A complete and up-to-date list of recalled lot numbers and product names can be found on the FDA website (https://www.fda.gov/) and the DermaRite website (https://www.dermarite.com/recall – link is hypothetical). Consumers are strongly urged to check these resources frequently as the list may be updated.

The Root Cause: Microbial Contamination

The primary concern driving the recall is the potential for microbial contamination, specifically Pseudomonas aeruginosa and Burkholderia cepacia. These bacteria can pose a serious health risk,particularly to individuals with compromised immune systems,burns,or open wounds. Infections caused by these microorganisms can be challenging to treat and may lead to severe complications.

The FDA inquiry revealed that inadequate quality control procedures during the manufacturing process contributed to the contamination. Specifically, issues with the sterilization and preservation of raw materials and finished products were identified. This highlights the critical importance of robust quality assurance systems in skincare manufacturing.

Health Risks Associated with contaminated products

Using skincare products contaminated with Pseudomonas aeruginosa or Burkholderia cepacia can lead to a range of adverse health effects:

* Skin Infections: Localized infections at the application site, characterized by redness, swelling, and pus.

* Pneumonia: Inhalation of contaminated product (e.g., during handwashing) can lead to pneumonia, especially in vulnerable populations.

* Bloodstream Infections (Sepsis): In severe cases, the bacteria can enter the bloodstream, causing sepsis, a life-threatening condition.

* Urinary Tract Infections: Contamination can also lead to UTIs.

Symptoms to Watch For: If you have used any of the recalled products and are experiencing symptoms such as fever, skin irritation, redness, swelling, or signs of infection, seek medical attention immediatly. Inform your healthcare provider about your use of the recalled product.

What to Do if You Have Recalled Products

The FDA and DermaRite are advising consumers to take the following steps:

1. Stop Using Immediately: Discontinue use of all recalled products immediately.
2. Check Your Products: Carefully examine your skincare products and compare them to the list of recalled lot numbers and product names on the FDA and DermaRite websites.
3. Contact DermaRite: Contact DermaRite Industries, LLC for instructions on how to return the products and receive a refund or replacement. Their contact information is available on their website and thru the FDA recall notice.
4. Report Adverse Events: Report any adverse reactions or health concerns related to the use of the recalled products to the FDA’s MedWatch program (https://www.fda.gov/safety/medwatch).

Impact on Healthcare Facilities & Long-term Care

The expanded recall has a particularly significant impact on healthcare facilities and long-term care centers, which often rely on bulk supplies of these skincare products. These facilities are urged to:

* Quarantine Affected Products: Immediately quarantine all recalled products to prevent further use.

* implement Choice Protocols: Establish alternative hand hygiene and skincare protocols using non-recalled products.

* Monitor Patients: Closely monitor patients for any signs of infection.

* Communicate with Staff: Inform all staff members about the recall and the necessary precautions.

Regulatory Scrutiny and Future Prevention

The DermaRite recall has prompted increased scrutiny from the FDA regarding skincare manufacturing practices.The agency is expected to conduct more frequent and rigorous inspections of skincare facilities to ensure compliance with Good manufacturing Practices (GMP).

Key areas of focus for future prevention include:

* Enhanced Quality Control: Implementing more robust quality control procedures throughout the manufacturing process.

* Improved Sterilization Techniques: Utilizing validated sterilization methods to eliminate microbial contamination.

* Raw Material Testing: Conducting thorough testing of all raw materials to ensure purity and safety.

* **Pres