UnratedDrug recall · FDA · Published June 30, 2021
Cascade Kelly Holdings Global Hand Sanitizer Recall: CGMP Deviations
Cascade Kelly Holdings recalls alcohol-based hand sanitizer with moisturizer due to CGMP deviations affecting denaturant quality. No remedy specified in official notice.
CGMP Deviations: Does not meet monograph for denaturant.
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Contact the company
📍Recalling firmCascade Kelly Holdings LLC81200 Kallunki Rd · Clatskanie, OR 97016-2244
✎ GovInfoNow plain-language explainer
Cascade Kelly Holdings is recalling their 8 fl. oz. alcohol-based hand sanitizer with moisturizer because it doesn't meet quality standards for denaturant. This could mean the product isn't as safe as it should be, but the recall doesn't include a specific fix or return process. Read more at govinfonow.com/recall/36104-cascade-kelly-holdings-global-hand-sanitizer-recall-cgmp-deviations.
“Cascade Kelly Holdings Global Hand Sanitizer Recall: CGMP Deviations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36104-cascade-kelly-holdings-global-hand-sanitizer-recall-cgmp-deviations. Based on FDA recall #D-0698-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0698-2021%22&limit=1).
Cascade Kelly Holdings LLC voluntarily recalled Global Hand Sanitizer with moisturizer due to CGMP deviations that cause the product to not meet the monograph for denaturant, according to the FDA. The Food and Drug Administration announced the recall on June 30, 2021.
How to tell if you have it
Brand: Cascade Kelly Holdings
Product: Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution
Size: 8 fl. oz./236 mL
Alcohol content: 80% v/v
NDC: 80253-001-02
Manufacturer: Cascade Kelly Holdings LLC
The hazard
The recalled hand sanitizer does not meet the monograph for denaturant due to CGMP deviations, according to the FDA. The record provides no information on incidents or injuries.
Context
GovInfoNow's records show other recent recalls of similar products include ACME Children's Hand Sanitizer Wipes Recall (2026-01-20), ACME UNITED Hand Sanitizing Wipes Recall (2026-01-20), and ACME WP WipesPlus Hand Sanitizing Wipes Recall (2026-01-20).
How to tell if you have this one
Look for the product name 'Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%'. Check the label for NDC 80253-001-02 and the 8 fl. oz./236 mL size.
Brand
Cascade Kelly Holdings
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
Recall number
Product, codes & lots
Quantity
D-0697-2021
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; All distributed lots within expiry
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D-0698-2021
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02; All distributed lots within expiry
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Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, size, and NDC number on the label to confirm it's the recalled item.
Where it went and when
Where it was distributed
Distributed in 9 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Maine, Massachusetts, New York, North Dakota, Oregon, Pennsylvania, Texas, Vermont.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0698-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0698-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.