FDA recall D-0697-2026

Product

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

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-0697-2026