Blaine Labs Inc: Terpenicol Antifungal Solution, (undecylenic (10-undecenoic) Acid 25%), 1.0 Fl Oz (29

TERPENICOL Antifungal Solution Recall Summary Blaine Labs Inc is recalling TERPENICOL Antifungal Solution (25% Undecylenic acid), 1.0 Fl Oz bottles nationwide due to the company discontinuing required stability testing on products still being sold before their expiration dates. The recall is classified as Class II and affects products distributed across all 50 states and Washington, D.C. Consumers with this product should check the NDC number 63347-600-01 to confirm whether they have the recalled item.

Recalling firm
Blaine Labs Inc
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
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-08
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/eb30cbb1-7bfd-4d4c-bd91-9dd6dfd9d32a