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.
What this means for you
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
- cgmp-deviation
- stability-testing-failure
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.
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