Lower risk Drug recall · FDA · Published April 8, 2026

Blaine Labs TERPENICOL Antifungal Solution Recall: CGMP Stability Testing Issue

Blaine Labs recalls TERPENICOL Antifungal Solution due to discontinued stability testing, risking product degradation. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0697-2026Drug Blaine Labs ›

Blaine Labs — official photo 1 — Official FDA recall photos · click to enlarge

Lower-risk recall

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Take action

Contact the company

Recalling firmBlaine Labs Inc11037 Lockport Pl · Santa Fe Springs, CA 90670-4634

✎ GovInfoNow plain-language explainer

Blaine Labs is recalling their TERPENICOL Antifungal Solution because they stopped required stability testing for products still within their expiration dates. This could lead to the product degrading over time, potentially affecting its effectiveness. Read more at govinfonow.com/recall/31351-blaine-labs-terpenicol-antifungal-solution-recall-cgmp-stability-testing-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/31351-blaine-labs-terpenicol-antifungal-solution-recall-cgmp-stability-testing-issue · Updated August 17, 2026 · FDA enforcement record: FDA #D-0697-2026

Cite this page

“Blaine Labs TERPENICOL Antifungal Solution Recall: CGMP Stability Testing Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31351-blaine-labs-terpenicol-antifungal-solution-recall-cgmp-stability-testing-issue. Based on FDA recall #D-0697-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0697-2026%22&limit=1).

The FDA announced on April 8, 2026, that Blaine Labs Inc is recalling TERPENICOL Antifungal Solution due to current good manufacturing practice deviations. The firm discontinued required stability testing for products still within their expiry dates.

How to tell if you have it

Brand: Blaine Labs
Product: TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL)
NDC: 63347-600-01
Lots: BL3411R, Exp Date 06/08/2027; BL3468, Exp Date 03/07/2027; BL3535, Exp Date 09/25/2027
Quantity: 5,801 bottles
Distribution: Nationwide in the USA

The hazard

The recall cites CGMP deviations because the firm discontinued required stability testing for products on the market still within their expiry. According to FDA's FAERS database, there are 20 adverse-event reports naming this product (NDC 63347-600), with 13 marked serious and one listing a death.

Context

GovInfoNow's records show Blaine Labs Inc has one other recall on record since Jan. 25, 2022: the RevitaDerm Wound Care Gel recall for Bacillus cereus contamination. Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), Wells Pharma Fentanyl Citrate Solution Recall (April 1, 2026), and Harbin Jixianglong Semaglutide Recall (Feb. 13, 2026).

How to tell if you have this one

Check the product label for the lot numbers BL3411R (expiring 06/08/2027), BL3468 (expiring 03/07/2027), or BL3535 (expiring 09/25/2027). The product is a 1.0 fl oz antifungal solution from Blaine Labs.

Brand
Blaine Labs
Category
Drug

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	Class	NDC
D-0692-2026	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.; Lot#: BL3608, Exp. 07/01/28.	1,171 - 1 oz bottles	Class I	—
D-0693-2026	TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.; Lot #: BL3435, Exp. 11/06/26	519 - 1 oz bottles	Class II	73352-520-01
D-0694-2026	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.; Lot #BL3411R, Exp 6/8/2027	144 bottles	Class II	73352-550-01
D-0695-2026	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.; Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.	22,143 bottles	Class II	63347-601-01
D-0696-2026	vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.; Lot BL3462, Exp. 2/7/2027	26,475 bottles	Class II	—
D-0697-2026	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; Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.	5,801 bottles	Class II	63347-600-01
D-0698-2026	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; Lot BL3572, Exp 04/16/2028	1,500 bottles	Class II	—
D-0699-2026	Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,; 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	5,555 bottles and tubes	Class II	63347-120-01, 63347-120-02

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for lot numbers BL3411R, BL3468, or BL3535 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

Apr 8, 2026Firm started the recall
Jul 8, 2026Published in FDA’s Enforcement Report
Jul 16, 2026FDA classified it Class II

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31351-blaine-labs-terpenicol-antifungal-solution-recall-cgmp-stability-testing-issue">Blaine Labs TERPENICOL Antifungal Solution Recall: CGMP Stability Testing Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0697-2026 (April 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0697-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.