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Home › FDA recalls › TRIPENICOL S Antifungal Solution
CLASS II · ModerateFDA

Blaine Labs Inc recalls TRIPENICOL S Antifungal Solution

📅 Apr 8, 2026 · 📍 Nationwide
Recalling company
Blaine Labs Inc
Product
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.
Reason
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 8, 2026
Reported
Jul 8, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
144 bottles
Lot / codes
Lot #BL3411R, Exp 6/8/2027
Company location
Santa Fe Springs, CA
Recall type
Voluntary: Firm initiated
Recall number
D-0694-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0694-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.