Lucky Super Soft athlete's foot cream recalled over manufacturing deviations
Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,102 tubes affected.
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 arising from inspection-observed manufacturing deviations with no product defect or consequence described, which fits the Moderate band.
Plain-English summary
Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, net weight 1.5 oz (42.5 g) tubes, manufactured for Delta Brands Inc. of Tarrytown, New York and made in India, UPC 8 08829 10461 5, is being recalled. The action covers 1,102 tubes.
The stated reason is CGMP deviations and deficiencies observed during an FDA inspection. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are 0001 and 0002, within expiry. Distribution was USA nationwide.
Consumers who have an affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
- Manufacturer
- Dabur India Limited
- Category
- Drug — Topical antifungal cream
- Affected units
- 1,102
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)
- Lot# 0001
- 0002
- within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Dabur India Limited 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 14 products in this recall →Related recalls
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