FDA Recall Alert: DermaRite Antiseptic Products Contaminated with Burkholderia Cepacia

DermaRite Industries Issues Nationwide Recall of Antiseptic Products

On August 8, 2025, DermaRite Industries, LLC announced a voluntary nationwide recall of several over-the-counter (OTC) antiseptic products, including DermaKleen, Dermasarra, Kleenfoam, and Perigiene, after testing revealed contamination with Burkholderia cepacia. The U.S. Food and Drug Administration (FDA) published the recall notice on August 9, 2025.

This recall highlights the serious risks associated with contaminated personal care products, particularly for immunocompromised individuals, and underscores the importance of monitoring for microbial contamination in healthcare and hygiene products.

Products Affected by the Recall

The recalled items include:

• DermaKleen: OTC antiseptic lotion soap with Vitamin E, used for handwashing to reduce bacteria on the skin.

• Dermasarra: OTC external analgesic, providing temporary relief from itching due to minor skin irritations, insect bites, sunburn, or dry skin.

• KleenFoam: OTC antimicrobial foam soap with Aloe Vera, recommended for handwashing after diaper changes, helping ill individuals, or prior to contact with medically vulnerable persons.

• PeriGiene: OTC antiseptic cleanser intended for use in the perineal area.

These products were distributed nationwide, including Puerto Rico, through various distributors and retail outlets.

Why the Recall Matters: Burkholderia cepacia Risks

The Burkholderia cepacia complex (BCC) is a group of bacteria that can cause serious infections. While healthy individuals with minor skin abrasions may experience localized infections, the risks increase significantly for those who are immunocompromised—including cancer patients, organ transplant recipients, and individuals with chronic illnesses.

For these vulnerable populations, BCC contamination can lead to life-threatening bloodstream infections (sepsis). Even in healthy people, the bacteria may cause skin infections if applied to minor wounds.

According to the FDA, DermaRite has not received reports of adverse events yet, but the potential severity of infections makes prompt action critical.

Steps Consumers Should Take

If you have any of the affected DermaRite products, the FDA and DermaRite advise:

1. Stop using the product immediately.

2. Check lot numbers against the recall notice to confirm if your items are affected.

3. Dispose of contaminated products safely according to local guidelines or facility processes.

4. Contact your healthcare provider if you suspect an infection or have symptoms such as redness, swelling, fever, or other signs of infection.

Consumers with questions can reach Mary Goldberg at 973-569-9000 x104 or email voluntary.action@dermarite.com.

Reporting Adverse Events

The FDA encourages anyone experiencing side effects or other problems from these products to report them through the MedWatch Adverse Event Reporting program:

• Online: www.fda.gov/medwatch/report.htm

• Mail or Fax: Download forms here or call 1-800-332-1088. Fax completed forms to 1-800-FDA-0178.

Reporting helps authorities track the extent of contamination and prevent further harm.

Why This Recall Is Significant

While recalls for OTC hygiene products may not always make headlines, this situation is especially concerning for healthcare settings. Products like KleenFoam are widely used in hospitals, clinics, and by caregivers for immunocompromised patients. Contamination with Burkholderia cepacia in such environments could contribute to severe outbreaks if not quickly addressed.

This recall serves as a reminder that even common antiseptic and hand washing products can carry hidden risks. Parents, caregivers, and healthcare workers must remain vigilant and check product recalls regularly.

KBD Attorneys’ Role in Protecting Consumers

At KBD we focus on protecting consumers from dangerous products, including contaminated medical and personal care items. While DermaRite has not reported injuries yet, contaminated products like these have the potential to cause serious, life-threatening infections, particularly for the most vulnerable populations.

Our attorneys are experienced in product liability cases involving defective or contaminated health and hygiene products. Families affected by contamination may have legal avenues for compensation if harm occurs.

Contact our team at KBD if you need legal help against this or any other dangerous product.

Key Takeaways

• Recall Date: August 8, 2025 (company), August 9, 2025 (FDA)

• Affected Products: DermaKleen, Dermasarra, Kleenfoam, Perigiene

• Contamination: Burkholderia cepacia

• Risk: Local infections in healthy individuals; severe bloodstream infections in immunocompromised patients

• Action: Stop use immediately, check lot numbers, dispose of affected products, consult healthcare provider if needed

• Report Issues: FDA MedWatch

Staying informed about recalls is crucial for personal safety and the safety of vulnerable loved ones.