FDA recall D-0694-2026

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-04-08

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Fe Springs, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0694-2026