FDAClass IIJuly 8, 2026

TRIPENICOL S Antifungal Solution recall: CGMP Deviations

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213…

Why was TRIPENICOL S Antifungal Solution recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #BL3411R, Exp 6/8/2027

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…
Recalling firm
Blaine Labs Inc
Quantity
144 bottles
Distribution
Nationwide in the USA
Recall date
July 8, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls