CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs
Blaine Labs is recalling vite20 Antifungal Cream, (10% Undecylenic Acid), distributed nationwide in the US. The recall was initiated on 8 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0696-2026
- FDA event ID
- 98731
- Recalling firm
- Blaine Labs, Santa Fe Springs, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2026
- FDA classified
- 16 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 8 Apr 2026 | Recall initiated by company | |
| 8 Jul 2026 | Published in enforcement report | +91 days |
| 16 Jul 2026 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Which lots are affected?
Lot BL3462, Exp. 2/7/2027
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 98731This product is part of a recall event; the main page for the event is Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine Labs.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine LabsTerpenicol | Blaine Labs | Potency & Assay | Nationwide | |
| CLASS II | Fungal Fusion Eradication Solution, Antifungal & Antimicrobial Kit recalled | Blaine Labs | Potency & Assay | Nationwide | |
| CLASS I | Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs | Blaine Labs | Sterility | Nationwide | |
| CLASS II | Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S | Blaine Labs | Potency & Assay | Nationwide | |
| CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol | Blaine Labs | Potency & Assay | Nationwide |
More recalls from Blaine Labs
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol | Blaine Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S | Blaine Labs | Potency & Assay | Nationwide |
| Drug | CLASS I | Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs | Blaine Labs | Sterility | Nationwide |