Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brands
- PeriGiene, DermaRite Industries LLC
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- PeriGiene, DermaRite Industries LLC
- Product type
- Antiseptic/Healthcare antiseptic
- Model numbers
- 31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1 +4 more
- UPC codes
- 61924-198, 61924-198-08, 61924-198-01
- Sizes
- 222 mL (7.5 fl oz)
- Sold at
- Unknown
- 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
PeriGiene Health Care Antiseptic is a consumer healthcare antiseptic product. It is used for cleansing and disinfecting skin in clinical settings.
Why This Is Dangerous
Contamination with Burkholderia cepacia can cause infection, especially in individuals with compromised immunity or chronic diseases.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate cessation of use to prevent potential infections; informed consumers may seek medical advice if exposed.
Practical Guidance
How to identify if yours is affected
- Verify product is PeriGiene Health Care Antiseptic
- Check NDC 61924-198-08 on packaging
Where to find product info
FDA recall page and product notification letters from DermaRite
What timeline to expect
Refunds or replacements are coordinated through the notifying party; timelines vary by provider.
If the manufacturer is unresponsive
- Document all contact attempts
- File a complaint with the FDA if company remains unresponsive
- Consider state attorney general resources if needed
How to prevent similar issues
- Purchase from authorized retailers
- Verify NDC numbers when buying antiseptics
- Watch for recall notices from FDA
- Register products with manufacturers where available
Documentation advice
Keep recall notices, take photos of packaging and lot information, log dates of contact with manufacturer
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Product Details
Model numbers: 31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1, 40877.1, 41093A, 50072A, 50079A. Sold nationwide in the USA. Size: 222 mL (7.5 fl oz) per bottle. NDC 61924-198-08. Brand: PERIGIENE. Manufacturer: DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. Recall date: 2025-07-17. Status: ACTIVE. Quantity: 5,703 bottles. Distribution: Nationwide within the USA.
Reported Incidents
No specific injuries or illness counts are provided in the recall notice. The FDA listing classifies the issue as Class I with high hazard.
Key Facts
- Bacteria: Burkholderia cepacia
- Bottles: 222 mL (7.5 fl oz)
- Sold nationwide in USA
- Class I recall
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Safety Guide
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