ICYMI: DermaRite Recall Due to Sepsis Risk Expands to Creams, Hair Products

Late last month, DermaRite Industries, LLC expanded its voluntary recall from July 2025 to now include various skin creams, hair products, and hand soaps due to potential microbial contamination of Burkholderia cepacia complex.¹

As stated in the company's and the FDA's announcement, Burkholderia cepacia complex can cause serious and life-threatening infections if the products are used by immunosuppressed individuals or by people caring for immunosuppressed individuals. For healthy individuals with minor skin lesions, the products may cause local infections, whereas in immunocompromised individuals, the infection could spread into the bloodstream, potentially leading to sepsis.^1,2

The products included in the expanded voluntary recall include:

• 4-N-1: A no-rinse wash cream intended to temporarily protect and help relieve chafed or cracked skin.
• DermaCerin: A skin protectant moisturizing cream indicated to temporarily protect and help relieve dry, chapped, or cracked skin. It also helps protect skin from the drying effects of wind and cold weather.
• DermaFungal: An OTC antifungal cream intended for the treatment and prevention of most athlete’s foot, jock itch, and ringworm. It relieves itching, scaling, cracking, and discomfort associated with these conditions.
• DermaKleen: An OTC healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
• DermaMed: An OTC skin protectant intended to dry the oozing and weeping of poison ivy, oak, or sumac, or other skin irritations.
• DermaSarra: An OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, or sunburn.
• Gel Rite: An OTC instant gel hand sanitizer with vitamin E used to decrease bacteria on the skin. It is recommended for repeated use.
• Hand E Foam: An OTC foaming hand sanitizer with vitamin E used for handwashing to decrease bacteria on the skin. It is recommended for repeated use.
• KleenFoam: An OTC antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
• Lantiseptic: An OTC skin protectant indicated to temporarily protect minor cuts, scrapes, and burns. It helps prevent and temporarily protect chapped or cracked skin.
• PeriGiene: An OTC antiseptic cleanser indicated for use in the perineal area.
• PeriGuard: An OTC skin protectant indicated to help relieve and prevent rashes and irritation due to wetness from incontinence. It also protects chafed skin due to irritation and helps seal out wetness.
• Renew Dimethicone: An OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritations associated with diaper rash, and helps seal out wetness.
• Renew Periprotect: An OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritation associated with diaper rash, and helps seal out wetness.
• Renew Skin Repair is an OTC Skin cream indicated to temporarily protect and help relieve chapped or cracked skin. It is beneficial for face, hands, body, and legs.
• UltraSure: An OTC anti-perspirant & deodorant indicated to reduce underarm wetness.

Click here to view item and lot numbers.

DermaRite products are sold at various large online and local retailers, including Amazon, Target, and Walmart.

The recalled products were distributed across the US and Puerto Rico. Distributors were notified by DermaRite via e-mail to check inventory and dispose of all affected products.

According to the company page, consumers with questions can contact Sedgwick at 888-943-5190 Monday through Friday, 8:00 am – 5:00 pm EST, or email dermarite5186@sedgwick.com.

Adverse reactions due to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Additionally, consumers should contact their health care provider regarding adverse events related to the product or if the product was used in the health care facility.

References

1. DermaRite Industries expands voluntary nationwide recall due to potential burkholderia cepacia contamination. News release. US Food and Drug Administration. August 28, 2025. Accessed September 10, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-expands-voluntary-nationwide-recall-due-potential-burkholderia-cepacia
2. DermaRite Industries expands voluntary nationwide recall due to potential burkholderia cepacia contamination. News release. DermaRite Industries. August 27, 2025. Accessed September 10, 2025. https://dermarite.com/dermarite-expands-voluntary-nationwide-recall/