16+ DermaRite Soaps, Creams, and Skin Protectants Linked to Dangerous Bacterial Contamination

FDA alert warns of Burkholderia cepacia complex contamination; immunocompromised users face sepsis risk.

DermaRite Industries has expanded a nationwide recall of multiple hygiene and skin-care products—hand soaps, cleansers, sanitizers, barrier creams, and related items—after testing indicated contamination with Burkholderia cepacia complex (BCC). For people with weakened immune systems, this bacterium can trigger invasive infections that may progress to life-threatening sepsis. The FDA’s latest update confirms the expansion covers additional products and lots distributed across the United States and Puerto Rico. Consumers are instructed to stop using the products immediately and dispose of them safely. Hospitals, nursing facilities, and caregivers should take special care, since these products are commonly used in clinical and long-term care settings.

What Was Recalled: Current Product List and Timeline

DermaRite’s initial mid-August recall covered DermaKleen, DermaSarra, KleenFoam, and PeriGiene over microbial contamination concerns. On August 28, 2025, the company expanded the recall to include 12 more products because of the same BCC risk: 4-N-1; DermaCerin; DermaFungal; DermaMed; Gel Rite; Hand E Foam; Lantiseptic; PeriGuard; Renew Dimethicone; Renew Periprotect; Renew Skin Repair; UltraSure. Specific lots and package sizes are listed in FDA postings and DermaRite’s press updates. If your product name appears on either list, treat it as recalled unless you can confirm your lot number is not affected.

Key points

• Products were sold nationally to consumers and into healthcare/long-term care channels.
• The recall is voluntary but FDA-reported; consumers should discard products or follow retailer return instructions.
• The reason: confirmed or potential contamination with Burkholderia cepacia complex.

The Health Hazard: What Is Burkholderia cepacia Complex?

Burkholderia cepacia complex (BCC) is a group of bacteria found in soil and water. It can survive in moist, low-nutrient environments, which is why it occasionally turns up in aqueous personal-care items. Healthy individuals exposed to intact skin may experience local infections if bacteria enter minor cuts. For immunocompromised people, including those undergoing chemotherapy, transplant recipients, individuals with chronic lung disease, uncontrolled diabetes, or frail nursing-home residents—BCC can invade the bloodstream and lead to sepsis, a body-wide inflammatory response that can cause organ failure and death without urgent treatment.

Why topical products are risky: many soaps, foams, and skin protectants are water-based. If manufacturing controls fail, bacteria can persist in the product and be spread directly onto vulnerable skin or devices (e.g., catheters, dressings).

Sepsis Warning Signs After Using a Recalled Product

If you used a recalled product and feel unwell, seek medical care promptly. Tell the clinician you may have been exposed to BCC through a recalled hygiene product—this context helps guide cultures and antibiotic choices.

Watch for:

• Fever, chills, sweats
• Fatigue, rapid heartbeat, low blood pressure, confusion
• Shortness of breath or worsening cough (especially in chronic lung disease)
• Worsening redness, tenderness, drainage, or non-healing skin breakdown around perineal areas or protected skin folds
• In frail adults: sudden decline, lethargy, or reduced urine output

Early evaluation matters because BCC can be resistant to multiple antibiotics; targeted therapy depends on lab identification and susceptibility testing.

What To Do If You Have a Recalled Product

1. Stop using it immediately.
2. Check product name and lot against the FDA/DermaRite lists. If in doubt, treat it as recalled.
3. Dispose safely: place in a sealed bag and discard per local guidance; avoid flushing. Clean any pumps, basins, or surfaces the product touched with standard disinfectants per label directions.
4. Document everything: keep photos of bottles (front/back), lot codes, purchase receipts, and a list of symptoms and medical visits.
5. Talk to your clinician if you notice any symptoms or if an immunocompromised person was exposed.

Facilities should pull affected inventory, quarantine returns, and alert staff. Consider notifying residents’ families if used in a long-term care setting.

Who Is Most at Risk?

• Immunocompromised adults (chemotherapy, transplant, high-dose steroids, advanced HIV).
• Residents of long-term care facilities or those with chronic wounds, indwelling devices, or incontinence-related skin care needs.
• People with chronic lung disease or cystic fibrosis, where BCC respiratory infection can be severe.
• Caregivers who apply these products to vulnerable patients.

How Contaminated Personal-Care Products Trigger Liability

When a consumer or patient is harmed by a contaminated hygiene product, several legal theories may apply:

• Product Liability (Manufacturing/Warning Defects): evidence that the product contained harmful bacteria or failed to include adequate risk instructions can support claims against the manufacturer and others in the distribution chain.
• Negligence: inadequate quality control, insufficient microbial testing, or failure to maintain sterile/clean manufacturing conditions.
• Breach of Warranty: the product’s implied promise of being safe and fit for its intended use was broken.
• Healthcare/Facility Negligence (where applicable): continued use of recalled stock on residents or failure to follow recall instructions.

Each case hinges on causation—linking the infection to the recalled product via medical records, cultures, timing of exposure, and product identification.

Evidence That Strengthens a Claim

• Product proof: photos of the bottle, labels, and lot number; purchase records; facility distribution logs.
• Medical proof: culture results showing Burkholderia cepacia complex, antibiotic susceptibility reports, hospitalization records, sepsis diagnoses, and clinician notes connecting exposure to the product.
• Damages documentation: bills, lost wages, caregiver costs, and records showing pain, disability, or long-term complications.

Prompt collection is vital because lot-specific labels and receipts can be misplaced, and facilities may quickly discard recalled stock.

Potential Compensation

Successful claims may recover:

• Medical expenses (ER visits, hospitalization, ICU care, antibiotics, rehabilitation)
• Lost income and diminished earning capacity
• Pain and suffering and loss of enjoyment of life
• Wrongful death damages for families (funeral costs, loss of financial support, and companionship)
• Out-of-pocket costs to replace safe hygiene supplies or for home modifications during recovery

Statutes of Limitations and Why Timing Matters

Every state sets deadlines for filing personal-injury and wrongful-death cases. Some states have discovery rules that start the clock when a reasonable person should recognize the injury may be linked to the product. Because BCC infections can be complex, and because the recall has expanded, waiting can jeopardize your rights. A timely legal evaluation preserves evidence and safeguards filing deadlines.

Special Considerations for Hospitals, Nursing Homes, and Home-Health Agencies

Healthcare providers and facilities should:

• Audit purchasing and supply chains for all DermaRite products on the recall lists.
• Document removal, quarantine, and disposal steps; keep copies of supplier notices.
• Update wound-care and perineal-care protocols; consider alternative products with verified lot testing.
• Track potentially exposed patients for new infections or sepsis signals and document notification efforts.

Patients and families may have claims if recalled products continued to be used after the FDA/DermaRite notices were available.

Current Status and Where to Verify Your Product

As of late August/early September 2025, the FDA confirms the recall expansion and continues to share updates through MedWatch and recall pages listing impacted names, sizes, and lot numbers. DermaRite’s site also posts press updates. Always verify details against official sources to confirm whether your specific item and lot are affected.

DermaRite Skin Product Lawsuit FAQs

1. Which products are included right now?
   Beyond the initial four (DermaKleen, DermaSarra, KleenFoam, PeriGiene), the expansion adds 12: 4-N-1, DermaCerin, DermaFungal, DermaMed, Gel Rite, Hand E Foam, Lantiseptic, PeriGuard, Renew Dimethicone, Renew Periprotect, Renew Skin Repair, and UltraSure. Lot-specific details appear in FDA postings.
2. I used one of these products and now feel sick. What should I do?
   Seek medical care promptly and explain the possible exposure. Ask about blood/urine/wound cultures and note the product name and lot if available. Then consider a legal consultation to protect your rights.
3. Do I need a positive culture for Burkholderia cepacia to pursue a claim?
   Lab confirmation is powerful evidence, but it is not the only path. Medical records, timing of symptoms, product identification, and clinician opinions can also support causation.
4. Can healthy people bring claims, or is this only for immunocompromised patients?
   Healthy users can experience local infections or other harm. Claims focus on contamination and injury, not just immune status. The highest risk remains for immunocompromised individuals.
5. What damages can be recovered?
   Medical bills, lost income, pain and suffering, and—when warranted—wrongful-death damages. Claims may also seek reimbursement for out-of-pocket costs and future care needs.
6. Is there a class action?
   Many product contamination cases proceed as individual lawsuits, mass torts, or coordinated actions. The appropriate route depends on your injuries, proof of exposure, and jurisdiction.
7. How long do I have to file?
   Deadlines vary by state and claim type. Some states toll or extend deadlines under discovery rules; others strictly enforce shorter periods. Early evaluation helps avoid missing the cutoff.
8. What evidence should I keep?
   Photograph the bottle and lot code, save receipts, maintain a symptom diary, and request copies of lab results. If exposure occurred in a facility, ask for your medication/skin-care administration records.
9. Are retailers or facilities also liable?
   Potentially. Responsibility can extend along the supply chain and to facilities that failed to remove recalled stock in a timely manner, depending on the facts and state law.
10. Will filing a claim help prevent future incidents?
    Beyond compensating victims, litigation can drive safer manufacturing and quality-control practices industry-wide.

Contact Parker Waichman LLP For A Free Case Review

If you or a family member suffered an infection or sepsis after using a recalled DermaRite hygiene product, legal help is available. Parker Waichman LLP is a national personal injury law firm actively investigating these cases and building claims for compensation. Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. We will review your facts, explain your options, and take swift steps to protect your rights.