FDA · Drugs · Wednesday, July 8

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) recall

Blaine Labs Inc recalled TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) on July 8, 2026 because of cGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry. It was sold nationwide.

Why it was recalled

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

What's recalled

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.

Quantity: 144 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company: Blaine Labs Inc, Santa Fe Springs, CA
Date: Wednesday, July 8
Severity: Class II
the product could cause temporary or reversible health problems.
Where sold: Nationwide
Nationwide in the USA
Status: Ongoing
Recall number: D-0694-2026
Source: U.S. Food and Drug Administration

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