FDA (Drugs) recall action 98731

Blaine Labs Inc recalled 8 products on 2026-07-08

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2026-07-08
Critical: 0
Units: 61,618

Why these products were recalled

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

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

SevereFDA (Drugs)··2026-07-08
Revitaderm Wound Care Gel recalled for microbial contamination
Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.
Product
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.
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
Terpenicol Antifungal Solution Recalled for CGMP Deviations
Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.
Product
TERPENICOL (UNDECYLENIC ACID)
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
vite20 Antifungal Cream recalled due to stability testing deviations
Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.
Product
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.
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
TERPENICOL Antifungal Cream Recalled for CGMP Deviations
Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.
Product
TERPENICOL (UNDECYLENIC ACID)
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
Fungal Fusion antifungal kit recalled for discontinued stability testing
Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.
Product
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
TRIPENICOL S Antifungal Solution Recalled for CGMP Deviations
Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) because the firm discontinued required stability testing for products still on the market within their expiration date.
Product
TRIPENICOL S (UNDECYLENIC ACID)
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
Tridergel Benzalkonium Chloride Wound Care Gel Recalled
Blaine Labs Inc is recalling Tridergel wound care gel nationwide due to current good manufacturing practice (CGMP) deviations. The product was manufactured in a facility under the same conditions as contaminated product.
Product
TRIDERGEL (BENZALKONIUM CHLORIDE)
Category
Distribution
0 states
ModerateFDA (Drugs)··2026-07-08
Revitaderm Wound Care Benzalkonium Chloride OTC Drug Recall
Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.
Product
REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
Category
Distribution
0 states