Elevated site urgencyFDA Class II

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 Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

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

Revitaderm Wound Care Gel, Benzalkonium Chloride 0

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.

Quantity: 1,171 - 1 oz bottles

Code or lot text: Lot#: BL3608, Exp. 07/01/28.

LOT: Exp. 07/01/28.
LOT: Lot#: BL3608
RECALL-NUMBER: D-0692-2026

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0

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,

Quantity: 5,555 bottles and tubes

Code or lot text: 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

LOT: 08/07/27
LOT: 11/06/26 & BL3525
LOT: BL3525
LOT: Exp 08/07/27. (b) 3 oz- Lots # BL3435
LOT: Exp 11/06/26
LOT: Lots: (a) 1 oz - BL3435
NDC: 63347-120
NDC: 63347-120-01
NDC: 63347-120-02
RECALL-NUMBER: D-0699-2026

TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1

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.

Quantity: 22,143 bottles

Code or lot text: Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.

LOT: Exp Date 08/30/2027.
LOT: Exp Date 10/13/26 & BL3528
LOT: Lots BL3431R
NDC: 63347-601
NDC: 63347-601-01
RECALL-NUMBER: D-0695-2026

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

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0

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.

Quantity: 519 - 1 oz bottles

Code or lot text: Lot #: BL3435, Exp. 11/06/26

LOT: Exp. 11/06/26
LOT: Lot #: BL3435
NDC: 73352-520
NDC: 73352-520-01
RECALL-NUMBER: D-0693-2026

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1

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.

Quantity: 144 bottles

Code or lot text: Lot #BL3411R, Exp 6/8/2027

LOT: Exp 6/8/2027
LOT: Lot #BL3411R
NDC: 73352-550
NDC: 73352-550-01
RECALL-NUMBER: D-0694-2026

vite20 Antifungal Cream, (10% Undecylenic Acid), 0

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.

Quantity: 26,475 bottles

Code or lot text: Lot BL3462, Exp. 2/7/2027

LOT: Exp. 2/7/2027
LOT: Lot BL3462
RECALL-NUMBER: D-0696-2026

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?

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 8/17/2026, 6:17:12 AM UTC.

2026-08-17T06:17:12.000Zupdated
2026-08-16T06:17:24.928Zcreated

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.