SURE Anti-Perspirant Recalled for Undeclared Active Ingredient Labeling Error
Idelle Labs is recalling SURE 48hr Confidence Anti-Perspirant 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 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: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard is a labeling error regarding the active ingredient, which fits the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Idelle Labs is recalling SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant, Net Wt 2.7 oz (76g). The product is distributed nationwide in the USA. The recall involves specific lots: 19279K1, 19279K2, and 19280K1.
The recall was initiated because the product contains an undeclared active ingredient (API). 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.
Consumers who have purchased this product should check the lot number on the packaging. If the lot number matches 19279K1, 19279K2, or 19280K1, they should stop using the product and contact Idelle Labs for further instructions or a refund.
The recalled product
- Product
- SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
- Manufacturer
- Idelle Labs
- Category
- Drug — OTC Topical
- 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 (3)
- Lots: 19279K1
- 19279K2
- 19280K1
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 →- LowIdelle Labs Recalls SURE Antiperspirant for Undeclared Active Ingredient
FDA (Drugs) · 2020-01-15
- ModerateIdelle Labs Recalls SURE 48 hr Anti-Perspirant for 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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