TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Agency
- FDA Drug
- Recall date
- Apr 8, 2026
- Status
- Ongoing
- Company
- Blaine Labs Inc
1. What product was recalled?
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc
Quantity: 1,500 bottles
Code or lot text: Lot BL3572, Exp 04/16/2028
- LOT
- Exp 04/16/2028
- LOT
- Lot BL3572
- RECALL-NUMBER
- D-0698-2026
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1
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
Quantity: 5,801 bottles
Code or lot text: Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
- LOT
- & BL3535
- LOT
- BL3468
- LOT
- Exp Date 03/07/2027
- LOT
- Exp Date 06/08/2027
- LOT
- Exp Date 09/25/2027.
- LOT
- Lots BL3411R
- NDC
- 63347-600
- NDC
- 63347-600-01
- RECALL-NUMBER
- D-0697-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.