CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report

Fungal Fusion Eradication Solution, Antifungal & Antimicrobial Kit recalled

Blaine Labs is recalling Fungal Fusion Eradication Solution, Antifungal & Antimicrobial Kit, distributed nationwide in the US. The recall was initiated on 8 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot BL3572, Exp 04/16/2028

Quantity recalled1,500 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0698-2026
FDA event ID: 98731
Recalling firm: Blaine Labs, Santa Fe Springs, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Apr 2026
FDA classified: 16 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

8 Apr 2026	Recall initiated by company
8 Jul 2026	Published in enforcement report	+91 days
16 Jul 2026	Classified by FDA	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot BL3572, Exp 04/16/2028

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 98731

This product is part of a recall event; the main page for the event is Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine Labs.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026	CLASS II	Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine LabsTerpenicol	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS I	Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs	Blaine Labs	Sterility	Nationwide
8 Jul 2026	CLASS II	Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026	CLASS II	vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026	CLASS II	Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol	Blaine Labs	Potency & Assay	Nationwide

More recalls from Blaine Labs

All 9

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS II	vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS II	Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S	Blaine Labs	Potency & Assay	Nationwide