HIGH

DermaSarra External Analgesic Recalled for Burkholderia Cepecia Contamination (DermaRite Industries)

DermaRite Industries recalled 249 bottles of DermaSarra External Analgesic on July 17, 2025 due to microbial contamination. The product, sold nationwide, carries NDC 61924-189-08 and Lot 40187.2 with an expiration date of February 2026. Consumers should stop using the product immediately and contact DermaRite for guidance.

Quick Facts at a Glance

Recall Date
July 17, 2025
Hazard Level
HIGH
Brands
DERMASARRA, DERMARITE INDUSTRIES LLC
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, INFANTS

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

DermaSarra is an external analgesic used for topical pain relief. It is sold as a 222 mL bottle. Typical use is for localized muscular or joint pain relief.

Why This Is Dangerous

Contamination with Burkholderia cepacia can pose infection risks, especially to vulnerable individuals with open wounds or compromised immune systems.

Industry Context

This recall is not part of a broader industry pattern mentioned in the data.

Real-World Impact

Immediate cessation is required. Consumers may face infection risk and require medical guidance. Financial impact includes disposal of recalled product and potential replacements.

Practical Guidance

How to identify if yours is affected

  1. Inspect the bottle for Lot 40187.2
  2. Check expiration date 02/2026
  3. Verify NDC 61924-189-08
  4. Confirm product volume 222 mL (7.5 fl oz)

Where to find product info

NDC 61924-189-08 on label; Lot 40187.2; Exp 02/2026

What timeline to expect

Recall notification letters will guide refunds or replacements; process timelines not specified

If the manufacturer is unresponsive

  • Document all correspondence
  • File a consumer complaint with FDA/CPSc if needed
  • Consult your healthcare provider for guidance

How to prevent similar issues

  • Check NDC numbers when purchasing OTC topical analgesics
  • Buy from reputable retailers
  • Review recall databases before using medications
  • Ensure sterile handling for topical products

Documentation advice

Keep recall notice, photos of label, receipts, and any medical advice received

Product Details

Brand: Dermasarra. Company: DermaRite Industries LLC. Product: DermaSarra External Analgesic. Size: 222 mL (7.5 fl oz) per bottle. NDC: 61924-189-08. Lot: 40187.2. Expiration: 02/2026. Quantity recalled: 249 bottles. Distribution: Nationwide in the USA.

Reported Incidents

No specific injuries or incidents are reported in the provided data.

Key Facts

  • 249 bottles recalled
  • NDC 61924-189-08
  • Lot 40187.2
  • Exp. 02/2026
  • Nationwide distribution 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
GENERALPREGNANTINFANTSCHILDRENELDERLYPETS
Injury Types
POISONINGFALLBURNELECTRICALLACERATIONOTHER

Product Details

Model Numbers
Lot #: 40187.2
Exp. Date 2/2026
UPC Codes
61924-189
61924-189-08
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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