Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Mi
Summary
The FDA issued a Class II for Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x by Blaine Labs Inc. Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.
Details
Source
Drug Recall
External ID
D-0698-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot BL3572, Exp 04/16/2028
Quantity Affected: 1,500 bottles
Reason for Recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-08
Company
Santa Fe Springs, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blaine Labs Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blaine Labs Inc have FDA actions?
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0698-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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