← FDA ENFORCEMENT
D-0698-2026Class II

Blaine Labs Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Blaine Labs Inc
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
Nationwide in the USA
Firm state
CA
Product quantity
1,500 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot BL3572, Exp 04/16/2028

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →