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.
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. 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
- Hazard
- cgmp-violation
- 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 (2)
- Lot BL3462
- Exp. 2/7/2027
Distribution
Distributed nationwide across the United States.
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