Blaine Labs: multiple drugs
Blaine Labs recalls multiple topical antiseptic/antifungal gels and creams due to Lysinibacillus fusiformis contamination.
Stop using the recalled products immediately and discard them. Contact Blaine Labs, Inc. for instructions on returning the product for a full refund.
Why it was recalled
Blaine Labs Inc. is recalling multiple topical antiseptic and antifungal products — including Revitaderm Wound Care Gel, TRIFLUENT PHARMA TRIDERGEL, TERPENICOL, Tripenicol, vite20, and Fungal Fusion products — due to microbial contamination with Lysinibacillus fusiformis. Using these non-sterile products may lead to skin or wound infections.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | NDC / UPC | Recall # |
|---|---|---|---|
| TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL) | BL3411R, 2027, BL3468, BL3535 | NDC 63347-600-01 | D-0697-2026 |
| 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 | BL3572, 2028 | – | D-0698-2026 |
| Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1% | BL3608 | NDC 63347-120-02 | D-0692-2026 |
| TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle | BL3411R, 2027 | NDC 73352-550-01 | D-0694-2026 |
| TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles | BL3431R, BL3528, 2027 | NDC 63347-601-01 | D-0695-2026 |
| TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy… | BL3435 | NDC 73352-520-01 | D-0693-2026 |
| Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) | – | NDC 63347-120-02, NDC 63347-120-01 | D-0699-2026 |
| vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle | BL3462, 2027 | UPC 6 16728 00039 2 | D-0696-2026 |
| Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) | BL3435, BL3525 | NDC 63347-120-02, NDC 63347-120-01 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification