Blaine Labs recalls Terpenicol, Tripenicol S, Revitaderm and Fungal Fusion antifungal and wound products over stopped stability testing
The company stopped the required stability testing on these products, which are still within their expiry dates, so it cannot show they stay safe and effective until they expire.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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; Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25%…
- Company
- Blaine Labs Inc
- Hazard
- CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Units
- 5,801 bottles; 1,500 bottles; 1,171 - 1 oz bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class I · Ongoing
- Classified by FDA
- July 16, 2026
- Recall started
- April 8, 2026
- FDA enforcement report
- July 8, 2026
- Identifiers
- Codes: Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
- FDA recall number: D-0697-2026
- Codes: Lot BL3572, Exp 04/16/2028
- FDA recall number: D-0698-2026
- Codes: Lot#: BL3608, Exp. 07/01/28.
- FDA recall number: D-0692-2026
- Codes: Lot #BL3411R, Exp 6/8/2027
- FDA recall number: D-0694-2026
- Codes: Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
- FDA recall number: D-0699-2026
- Codes: Lot BL3462, Exp. 2/7/2027
- FDA recall number: D-0696-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 | 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 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
- Reason for recall
- CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Classification
- Class I (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 5,801 bottles; 1,500 bottles; 1,171 - 1 oz bottles; 144 bottles; 5,555 bottles and tubes; 26,475 bottles
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