FDA recall D-0695-2026

Product

TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.

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-0695-2026