Skip to main content

FDA recall, , High risk

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions have manufacturing deviations or bacterial contamination.

Summary by Recall Canary from the FDA notice

What happened

Blaine Labs is recalling 8 products; the recall covers several hazards, including CGMP deviations and stability testing.

More contamination recalls

3 photos

What to do

If a code on your package is listed below:

  1. Consumers with questions regarding this recall can contact Blaine Labs, Inc directly by using the contact information listed below Monday through Friday 7:30AM to 4:00PM PST.
  2. You may also report adverse events or questions regarding this recall directly to Blaine Labs using the contact information below.Blaine Labs, Inc. Phone: (800) 307-8818 Address: 11037 Lockport Pl, Santa Fe Springs, California, 90670 Email: Contact@blainelabs.com.
  3. Customers & Healthcare providers should review their inventory for these affected lot number and discontinue use and / or distribution immediately.
  4. Immediately stop using the product. Segregate any remaining inventory of these lot numbers and please contact Blaine Labs, Inc to arrange for return.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.

  1. Product details

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc

    Lot code
    • BL3572

  2. Terpenicol Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL)

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    NDC
    • 63347-600-01
    Lot code
    • BL3411R
    • BL3468
    • BL3535

  3. Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%

    Reason: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

    NDC
    • 63347-120-02
    Lot code
    • BL3608

  4. Tripenicol S Antifungal Solution (Undecylenic Acid 25%), 1.25 fl oz (37.5 mL) bottle

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    NDC
    • 73352-550-01
    Lot code
    • BL3411R

  5. Terpenicol Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    NDC
    • 63347-601-01
    Lot code
    • BL3431R
    • BL3528

  6. Trifluent Pharma Tridergel Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap

    Reason: CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

    NDC
    • 73352-520-01
    Lot code
    • BL3435

  7. Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%)

    Reason: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

    NDC
    • 63347-120-02
    • 63347-120-01
    Lot code
    • BL3435
    • BL3525

  8. vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    UPC
    • 6 16728 00039 2
    Lot code
    • BL3462

Recall details

Company began the recall
Sold in

Nationwide in the USA

Company
Blaine Labs IncSanta Fe Springs, California
Hazard
Contamination
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98731
Recall numbers
D-0692-2026 to D-0699-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. In FDA's weekly enforcement report

  5. Classified by FDA

  6. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 24, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)