Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brands
- KleenFoam, DermaRite Industries LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- KleenFoam, DermaRite Industries LLC
- Product type
- Antimicrobial Foam Soap
- Model numbers
- 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053C +3 more
- UPC codes
- 61924-093, 61924-093-34
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 17, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact DermaRite Industries, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
KleenFoam Antimicrobial Foam Soap is designed for hand cleanliness and infection prevention in healthcare settings and personal use. Consumers typically buy it for its antimicrobial properties and moisturizing effects from aloe vera.
Why This Is Dangerous
The contamination with Burkholderia cepacia presents a significant risk as it can lead to infections, especially in vulnerable populations. This defect is particularly concerning due to the product's nature as a soap intended for hygiene.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall causes inconvenience as consumers must stop using the product and seek alternatives, especially in healthcare settings where hygiene is critical.
Practical Guidance
How to identify if yours is affected
- Check the label for the model number listed in the recall.
- Verify the NDC number: 61924-093-34.
- Look for packaging from the recalled date range.
Where to find product info
The model number and NDC number are typically found on the product's label or packaging.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing once the return is initiated.
If the manufacturer is unresponsive
- Follow up with DermaRite Industries via their contact methods.
- Document your communication and attempts to reach them.
- Consider filing a report with the FDA if the issue persists.
How to prevent similar issues
- Always check for recalls before purchasing health products.
- Look for third-party certifications for safety and quality.
- Avoid products with ambiguity regarding their sterility and safety.
Documentation advice
Keep receipts, packaging, and any correspondence with DermaRite Industries for your records.
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Product Details
- Brand: KleenFoam - Manufacturer: DermaRite Industries LLC - Model Numbers: 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053C, 41053A, 41053B, 50017A - Quantity: 6,973 cartridges - NDC: 61924-093-34 - Distribution: Nationwide in the USA
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Contaminated with Burkholderia cepacia
- Class I recall - serious health risk
- Sold nationwide in the USA
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Safety Guide
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