Recall: D-0694-2026

Class II - Potentially Harmful

Class IIClassification
2026-04-08Initiated
OngoingStatus
Blaine Labs IncFirm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.