The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0695-2026·Announced 2026-07-08

TERPENICOL Antifungal Cream Recalled for CGMP Deviations

Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.

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 with no reported illnesses or injuries. The hazard relates to a manufacturing practice deviation (discontinued stability testing) rather than confirmed product contamination or defect, making it a precautionary, moderate-severity action.

Plain-English summary

Blaine Labs Inc is recalling TERPENICOL Antifungal Cream (Undecylenic Acid 13%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The firm discontinued required stability testing for products currently on the market that are still within their expiration dates.

The recalled product is TERPENICOL Antifungal Cream in 1.0 oz (28 g) bottles. The recall involves 22,143 bottles from Lots BL3431R (Exp Date 10/13/26) and BL3528 (Exp Date 08/30/2027), manufactured by Blaine Labs, Inc., located at 11037 Lockport Place, Santa Fe Springs, CA 90670 (NDC 63347-601-01).

Consumers in possession of the recalled product should stop using it and contact the recalling firm for further instructions. The FDA is monitoring the situation. For more information, visit the FDA's drug recalls webpage.

The recalled product

Product
TERPENICOL (UNDECYLENIC ACID)
Brand
TERPENICOL
Manufacturer
Blaine Labs Inc
Category
Drug — Topical Antifungal / OTC
Hazard
Affected units
22,143

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 (3)

  • Lots BL3431R
  • Exp Date 10/13/26 & BL3528
  • Exp Date 08/30/2027.

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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