Idelle Labs Recalls SURE Antiperspirant for Undeclared Active Ingredient
Idelle Labs is recalling SURE 48hr Confidence Nourishing Coconut Antiperspirant & Deodorant because the label lists an active ingredient that is not actually in the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a violation or deviation from GMP or labeling that is not likely to cause adverse health consequences.
Plain-English summary
Idelle Labs is recalling SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant, Net Wt 2.6 oz (73g). The product is identified by NDC# 41595-5547-1 and UPC 8 83484 31020 5. The specific lot number is 19277K1.
The recall was initiated because the product contains an undeclared active ingredient. Specifically, the active ingredient listed on the label is not the active ingredient actually present in the product. This is a labeling discrepancy regarding the product's formulation.
The product was distributed nationwide in the USA. Consumers who have this specific product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
- Manufacturer
- Idelle Labs
- Category
- Drug — OTC Antiperspirant
- 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 (1)
- Lot: 19277K1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Idelle Labs 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 4 products in this recall →Related recalls
Same manufacturer · Idelle Labs
See all →- ModerateIdelle Labs Recalls SURE 48 hr Anti-Perspirant for Labeling Error
FDA (Drugs) · 2020-01-15
- ModerateSURE Anti-Perspirant Recalled for Undeclared Active Ingredient Labeling Error
FDA (Drugs) · 2020-01-15
- ModerateIdelle Labs Recalls SURE 48hr Anti-Perspirant Due to Labeling Error
FDA (Drugs) · 2020-01-15
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