The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0697-2026·Announced 2026-07-08

Terpenicol Antifungal Solution Recalled for CGMP Deviations

Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their 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 involving CGMP deviations related to discontinued stability testing. The source text does not report any illnesses, injuries, or deaths, and the hazard is procedural/regulatory rather than an identified product contamination or defect. The recall is precautionary based on manufacturing compliance failures.

Plain-English summary

Blaine Labs Inc is recalling Terpenicol Antifungal Solution (Undecylenic Acid 25%, 1.0 Fl Oz / 29.6 mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm discontinued required stability testing for products that are still being distributed and remain within their expiration dates.

The recalled product includes 5,801 bottles with the following lot numbers and expiration dates: Lot BL3411R (Exp Date 06/08/2027), Lot BL3468 (Exp Date 03/07/2027), and Lot BL3535 (Exp Date 09/25/2027). The product was manufactured by Blaine Labs, Inc., located at 11037 Lockport Place, Santa Fe Springs, CA 90670 (NDC 63347-600-01).

Consumers who have purchased this product should stop using it. Contact your healthcare provider or pharmacist if you have questions or concerns.

The recalled product

Product
TERPENICOL (UNDECYLENIC ACID)
Brand
TERPENICOL
Manufacturer
Blaine Labs Inc
Category
Drug — OTC Antifungal
Hazard
Affected units
5,801

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 (6)

  • Lots BL3411R
  • Exp Date 06/08/2027
  • BL3468
  • Exp Date 03/07/2027
  • & BL3535
  • Exp Date 09/25/2027.

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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