Antifungal Powder Recalled Due to Low Active Ingredient Content
Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.
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: FDA Class II recall for insufficient active ingredient (low assay). No hospitalizations, illnesses, or injuries reported. The hazard is a manufacturing quality and potency issue rather than contamination or direct safety threat.
Plain-English summary
REMEDY Antifungal, a topical antifungal powder manufactured by Medline Industries, is being recalled nationwide. The recalled product is a 3-ounce (85 grams) tube with miconazole nitrate 2.0% active ingredient and vanilla scent (product number NDC 53329-169-79). The affected lot is #007782 with expiration date August 31, 2024.
The recall was initiated because the product was released from the manufacturer to distribution while investigation for low assay results was still ongoing. The product was found to contain insufficient miconazole nitrate compared to the labeled concentration. This release prior to completed testing represents a violation of Current Good Manufacturing Practice (CGMP) standards.
Consumers who have purchased this product should consult a healthcare provider regarding alternative treatments for fungal infections.
The recalled product
- Product
- REMEDY ANTIFUNGAL (MICONAZOLE NITRATE)
- Brand
- REMEDY ANTIFUNGAL
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Drug — OTC Topical Antifungal
- Hazard
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 007782
- Exp 08/31/2024
UPCs (1)
- 0080196528564
Distribution
Distributed nationwide across the United States.
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