D-0697-2026 Class II Ongoing
FDA drug recall D-0697-2026 was initiated by Blaine Labs Inc on April 8, 2026 and is designated Class II. Reason for recall: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry The recall status is ongoing. Affected quantity: 5,801 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- April 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,801 bottles
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
Reason for Recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Distribution Pattern
Nationwide in the USA
Code Information
Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.