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Dermasarra Recall Lawsuit | 2026 Latest Updates

Dermarite Industries has issued a nationwide recall of its Dermasarra skin care products due to potential bacterial contamination that could cause serious infections in vulnerable individuals. Consumers are advised to stop using the affected items immediately and follow recall instructions to ensure their safety.

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Table of contents
  1. Latest Dermasarra Recall Updates
  2. September 11, 2025: ABC News Reports on the Expanded Recall
  3. September 8, 2025: DermaRite Tells Customers Wound Care Products Are Not Recalled
  4. August 27, 2025: DermaRite Expands the Recall to More Products
  5. August 9, 2025: FDA Posts the DermaRite Recall Announcement
  6. Which Dermasarra Are Affected?
  7. Why Was Dermasarra Recalled?
  8. Reported Incidents, Injuries, or Illnesses
  9. What Should Consumers Do?
  10. Other Recalls, Warnings, or International Actions
  11. Legal Options
  12. Frequently Asked Questions
  13. What Is Dermasarra Used For?
  14. What Are the Symptoms of Burkholderia Cepacia Infection?
  15. Who Is at Higher Risk from Burkholderia Cepacia?
  16. Which Expiration Dates Does the Expanded Recall Cover?
  17. References
DermaRite Industries recalled Dermasarra, an itch-relief lotion, along with lots of DermaKleen, KleenFoam and PeriGiene. The voluntary nationwide recall was announced on August 8, 2025, and later expanded. The FDA posted it on August 9, 2025. The lots may carry Burkholderia cepacia complex, which may cause serious and life-threatening infections, including sepsis in people with weak immune systems. If you have an affected product, stop using it and call your doctor about any health problem. No lawsuit, MDL or class action over the DermaRite recall has been filed.
Recall at a glance
  • Action type: Voluntary nationwide recall of individual lots (drug)
  • Announcement and initiation dates: Announced August 8, 2025; FDA posted August 9, 2025; expanded August 27, 2025
  • Company and responsible agency: DermaRite Industries, LLC and the FDA
  • Recall or campaign number: Not stated in the notice
  • Affected models, lots, UPCs, serial numbers, or VINs: Lots in the notice’s product table; DermaSarra 7.5 oz bottle, reorder # 00188
  • Number of affected units: Not stated in the notice
  • Sold at and sale period: Distributed nationwide in the United States and in Puerto Rico; sale period and price not stated in the notice
  • Hazard: Burkholderia cepacia complex contamination, which may cause serious infections, including sepsis in people with weak immune systems
  • Reported incidents, injuries, illnesses, and deaths: DermaRite reported no adverse events when it announced the recall
  • Remedy: Distributors were told to destroy affected products; consumers can call 973-569-9000 x104 or email voluntary.action@dermarite.com

Latest Dermasarra Recall Updates

September 11, 2025: ABC News Reports on the Expanded Recall

ABC News reported on the letter DermaRite sent to customers. It also covered the August 27 expansion of the recall, which includes DermaSarra, the itch-relief lotion [1]. The report says the company had not said whether it had received any reports of adverse reactions. All recalled items were distributed in the U.S. and Puerto Rico.

September 8, 2025: DermaRite Tells Customers Wound Care Products Are Not Recalled

DermaRite told customers in a letter that its wound care and nutritional products are not part of the recall [2]. The company posted the letter as a press release dated September 8, 2025, after it widened the recall to more products on August 27.

August 27, 2025: DermaRite Expands the Recall to More Products

DermaRite expanded the voluntary nationwide recall to more of its products, including DermaSarra. The cause is potential microbial contamination of Burkholderia cepacia complex. Dermatology Times reported the expansion [3]. The company had first announced the recall on August 8, 2025, for four brands. The expansion added products beyond those four.

August 9, 2025: FDA Posts the DermaRite Recall Announcement

The FDA posted DermaRite’s company announcement of the voluntary nationwide recall on August 9, 2025 [4]. DermaRite told distributors and customers by e-mail to examine inventory and destroy all affected products.

Which Dermasarra Are Affected?

The announcement named four DermaRite brands:
  • DermaSarra: an over-the-counter external analgesic lotion for temporary itch relief, with camphor and menthol, in a 222 mL (7.5 oz) pump bottle
  • DermaKleen: an over-the-counter antiseptic lotion soap with Vitamin E for handwashing
  • KleenFoam: an over-the-counter antimicrobial foam soap with Aloe Vera for handwashing
  • PeriGiene: an over-the-counter antiseptic cleanser for use in the perineal area
The FDA notice lists the recalled lots in a product table image. The DailyMed drug label for the 222 mL DermaSarra pump bottle shows NDC 61924-189-08 [5]. DermaRite lists the bottle as reorder # 00188.

Why Was Dermasarra Recalled?

Dermasarra was recalled because of microbial contamination with Burkholderia cepacia in individual lots. DermaRite made this announcement and the FDA posted it. The notice says Burkholderia cepacia complex in these products may result in serious and life-threatening infections. The company says people with weak immune systems, or people caring for them, may use the products. In those people, the infection is more likely to spread into the bloodstream. This may lead to sepsis, which can be life-threatening. The August 27 expansion cited potential contamination with the same bacteria.

Reported Incidents, Injuries, or Illnesses

In its August 2025 announcement, DermaRite said it had received no reports of adverse events related to the recall. TODAY reported that many Burkholderia cepacia complex germs resist antibiotics, so treatment is harder [6]. A report alone does not prove that a product caused an illness. A lack of reports also does not show that no one was harmed.
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What Should Consumers Do?

Take these steps if you have a DermaRite product at home:
  1. Check your DermaSarra, DermaKleen, KleenFoam or PeriGiene bottle against the lot list in the FDA notice.
  2. Stop using any affected product and dispose of it.
  3. Call DermaRite at 973-569-9000 x104, Monday through Friday, 9:00 am to 5:00 pm EST, or email voluntary.action@dermarite.com.
  4. Contact your doctor or healthcare provider about any problem that may be related to using the product.
  5. Contact your doctor if you notice respiratory problems, fever or fatigue after using an affected product, the symptoms ABC News lists from the CDC.
  6. Report adverse reactions to the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm, or call 1-800-332-1088 to request a form.

Other Recalls, Warnings, or International Actions

On August 27, 2025, DermaRite expanded the recall to more products. The expansion added these products, according to ABC News:
  • 4-N-1 no-rinse wash cream, DermaCerin and DermaFungal
  • DermaMed, Gel Rite and Hand E Foam
  • Lantiseptic, PeriGuard and Renew Dimethicone
  • Renew Periprotect, Renew Skin Repair and UltraSure
A recall alone does not automatically make a company liable or a person eligible for compensation. Someone who became ill after using a recalled product can ask a lawyer to review the facts. Keep the product and purchase records.

Frequently Asked Questions

What Is Dermasarra Used For?

Dermasarra is used for temporary relief of itching from minor skin irritations. DermaRite lists dry skin, poison ivy, poison oak, poison sumac, insect bites, detergents and sunburn. Its page says the menthol soothes and cools irritated skin.

What Are the Symptoms of Burkholderia Cepacia Infection?

Symptoms of Burkholderia cepacia infection may include respiratory problems, fever or fatigue, according to ABC News citing the CDC. Some infected people have no symptoms. In healthy people with minor skin lesions, the notice says local infections are more likely.

Who Is at Higher Risk from Burkholderia Cepacia?

People at higher risk from Burkholderia cepacia include those with a weak immune system or a chronic lung condition such as cystic fibrosis. ABC News attributes this to the CDC. These people are more likely to become infected.

Which Expiration Dates Does the Expanded Recall Cover?

The expanded recall covers products with expiration dates from July 2025 to August 2027, according to ABC News. Compare the expiration date and lot on your label with the lot list in DermaRite’s notice before you decide what to do.

References

  1. https://abcnews.com/GMA/Living/hand-soaps-cleansers-voluntarily-recalled-due-bacteria-contamination/story?id=124573121
  2. https://dermarite.com/dermarite-recall-update-9-8-25/
  3. https://www.dermatologytimes.com/view/icymi-dermarite-recall-due-to-sepsis-risk-expands-to-creams-hair-products
  4. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and
  5. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1fad8650-8bd6-4711-9121-b9f6ff8bdf6b
  6. https://www.today.com/health/recall/skin-care-products-recall-2025-rcna231003