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Blaine Labs

8 recalls on record · Last recall: Apr 8, 2026

Read the history in context

Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
1
Class II — Moderate
7
Class III — Low Risk
0

Categories

MEDICATION

Recall Timeline

Class IIFDAApr 8, 2026

Blaine Labs — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IIFDAApr 8, 2026

Blaine Labs — 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 CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IFDAApr 8, 2026

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

Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Class IIFDAApr 8, 2026

Blaine Labs — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IIFDAApr 8, 2026

Blaine Labs — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Class IIFDAApr 8, 2026

Blaine Labs — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2. CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IIFDAApr 8, 2026

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

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01. CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

Class IIFDAApr 8, 2026

Blaine Labs — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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