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FDAFDA recall D-0698-2026 · Jul 8, 2026

Blaine Labs Inc: Fungal Fusion ERADICATION Solution recall

Recall found

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

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
Lot BL3572, Exp 04/16/2028
Quantity
1,500 bottles
Distribution
Nationwide in the USA
Recalling firm
Blaine Labs Inc, Santa Fe Springs, CA
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-04-08

Source: openFDA enforcement record D-0698-2026 · search recall number D-0698-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.

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