HIGHFDA DRUG

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
July 17, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
DERMASARRA, DERMARITE INDUSTRIES LLC
Product type
Topical Analgesic
Model numbers
Lot #: 40187.2, Exp. Date 2/2026
UPC codes
61924-189, 61924-189-08
Sizes
222 mL (7.5 fl oz) per bottle
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    July 17, 2025

  2. Reported by FDA DRUG

    September 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. 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

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.

Practical Guidance

How to identify if yours is affected

  1. Inspect the bottle for Lot 40187.2
  2. Check expiration date 02/2026
  3. Confirm product volume 222 mL (7.5 fl oz)

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

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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

  • 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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