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Medium risk Drugs & MedicationsClass II

Blaine Labs TERPENICOL Antifungal Solution Recall

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockp

Updated April 8, 2026

Blaine Labs is recalling TERPENICOL Antifungal Solution because the manufacturer stopped required safety testing for products still being sold. The company did not maintain proper quality controls, which means the product's safety and effectiveness may not be guaranteed.

Is the Blaine Labs Inc recalled? Yes. This product was recalled by FDA on April 8, 2026. Details below.

What is recalled

TERPENICOL Antifungal Solution (Undecylenic acid 25%), 1.0 Fl Oz (29.6 mL), NDC 63347-600-01, manufactured by Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670.

Am I affected

You're affected if you own a bottle of TERPENICOL Antifungal Solution with NDC number 63347-600-01 that is still within its expiration date.

What to do right now

Stop using this product. Contact Blaine Labs, Inc. or return the product to the place of purchase for a refund or replacement.

The hazard

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

Brands affected

Blaine Labs Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0697-2026
Classification
Class II
Recalled
April 8, 2026
Read the official notice

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