D-0695-2026 Class II Ongoing
FDA drug recall D-0695-2026 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: 22,143 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
- 22,143 bottles
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
Distribution Pattern
Nationwide in the USA
Code Information
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.