Terpenicol Liquid
FDA Recall NDC 63347-600
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Terpenicol (NDC 63347-600). A significant event, classified as Class II, was initiated on Apr 08, 2026 by Blaine Labs Inc.. The reported reason for this action was: "CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Recall Number
Class II Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Apr 08, 2026
Jul 08, 2026
5,801 bottles
Recall Profile & Regulatory Data
Event ID
98731
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blaine Labs Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Affected Packages Involved in this Recall
63347-600-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
