FDA recall D-0698-2026

Blaine Labs Inc · Class II · drug

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 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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-04-08
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Fe Springs, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2026