HIGH

PeriGiene Health Care Antiseptic Recalled for Burkholderia Contamination (2025)

Five thousand seven hundred three bottles recalled nationwide for microbial contamination with Burkholderia cepacia. DermaRite Industries LLC issued the recall on July 17, 2025. The product is PeriGiene Health Care Antiseptic, 222 mL bottles. Consumers should stop use and contact DermaRite for guidance.

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

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

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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

  1. Verify product is PeriGiene Health Care Antiseptic
  2. Check NDC 61924-198-08 on packaging
  3. Review model numbers listed (31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1, 40877.1, 41093A, 50072A, 50079A)

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

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

  • 5,703 bottles recalled
  • Bacteria: Burkholderia cepacia
  • NDC 61924-198-08
  • Bottles: 222 mL (7.5 fl oz)
  • Sold nationwide in USA
  • Class I recall

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGOTHERELECTRICAL

Product Details

Model Numbers
31013A
40345A
40355A
40571A
40580A
+7 more
UPC Codes
61924-198
61924-198-08
61924-198-01
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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