Warning
Blaine Labs Inc Recalls TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0695-2026Drug / Pharmaceutical
Blaine Labs Inc Recalls TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
Blaine Labs Inc · Class II — Moderate Risk
Product Description
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Blaine Labs Inc has recalled a pharmaceutical product that the FDA classified as Class II affecting 22,143 bottles. The recall was initiated on April 8, 2026. CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.