Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0696-2026·Announced 2026-07-08

vite20 Antifungal Cream recalled due to stability testing deviations

Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is a CGMP deviation involving failure to conduct required stability testing, which is a quality/compliance issue rather than a direct health threat. The source text does not report any illnesses or injuries, and the products remain within labeled expiration dates, making this a precautionary recall.

Plain-English summary

Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid), 0.54 OZ (15 g) bottles, UPC 6 16728 00039 2, Lot BL3462, Exp. 2/7/2027. The recall affects approximately 26,475 bottles distributed nationwide in the USA.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The firm discontinued required stability testing for products that remain on the market and are still within their expiration date. Stability testing is required to ensure that a drug product maintains its safety and efficacy throughout its labeled shelf life.

Consumers who have purchased this product should stop using it and contact Blaine Labs Inc for further instructions or a refund. Consumers with questions or who believe they have been harmed may contact the FDA or seek medical advice.

The recalled product

Product: 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.
Manufacturer: Blaine Labs Inc
Category: Drug — Topical / Over-the-Counter
Hazard: cgmp-violation
stability-testing-failure
Affected units: 26,475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot BL3462
Exp. 2/7/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Blaine Labs Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Blaine Labs Inc

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Same hazard · cgmp violation