Blaine Labs Inc recalls TERPENICOL Antifungal Solution
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Apr 8, 2026
- Reported
- Jul 8, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 5,801 bottles
- Lot / codes
- Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
- Company location
- Santa Fe Springs, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0697-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0697-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.