Blaine Labs Inc Recalls

8 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Drug Recalls (8)

April 8, 2026
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 II
April 8, 2026
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
Class II
April 8, 2026
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
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II
April 8, 2026
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Un
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II
April 8, 2026
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 ca
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II
April 8, 2026
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 II
April 8, 2026
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 II
April 8, 2026
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
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class I

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