Global Hand Sanitizer Recalled Due to Denaturant Deficiency
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.
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: This is an FDA Class II recall involving a manufacturing/formulation deviation (missing denaturant). The source text does not report any illnesses, injuries, or confirmed harms, making this a precautionary quality/compliance issue rather than an immediate safety threat. Class II recalls with no reported adverse events typically score 2.
Plain-English summary
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer (80% alcohol, 4 fl. oz./119 mL bottles, NDC 80253-001-01) distributed to affiliated facilities and donated to third-party recipients in Connecticut, Massachusetts, Maine, North Dakota, New York, Oregon, Pennsylvania, Texas, and Vermont.
The recall was initiated because the product does not meet the pharmaceutical monograph requirement for denaturant content. This is a Current Good Manufacturing Practice (CGMP) deviation that affects the product's compliance with federal standards for alcohol-based antiseptics.
All distributed lots within their expiration date are included in this recall. Consumers who have this product should stop using it and consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
- Manufacturer
- Cascade Kelly Holdings LLC
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)
- All distributed lots within expiry
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cascade Kelly Holdings LLC 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 2 products in this recall →Related recalls
Same manufacturer · Cascade Kelly Holdings LLC
See all →- ModerateGlobal Hand Sanitizer with Moisturizer Recalled for Denaturant Deviation
FDA (Drugs) · 2021-08-11
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