The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0694-2026·Announced 2026-07-08

TRIPENICOL S Antifungal Solution Recalled for CGMP Deviations

Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) because the firm discontinued required stability testing for products still on the market within their expiration date.

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 involving CGMP deviations (discontinuation of stability testing). No illnesses or injuries are reported in the source text, and the hazard is a manufacturing process deviation rather than confirmed product contamination or defect. FDA Class II recalls without reported illness or injury typically fall in the Moderate range.

Plain-English summary

Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottles, NDC 73352-550-01, Lot #BL3411R with expiration date 6/8/2027. 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.

A total of 144 bottles were distributed nationwide in the USA. Consumers who have purchased this product should stop using it and consult their healthcare provider with any questions or concerns.

The recalled product

Product
TRIPENICOL S (UNDECYLENIC ACID)
Brand
TRIPENICOL S
Manufacturer
Blaine Labs Inc
Category
Drug — OTC Antifungal Topical
Hazard
Affected units
144

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 #BL3411R
  • Exp 6/8/2027

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 →

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