Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported August 11, 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
CGMP Deviations: Does not meet monograph for denaturant.
Cascade Kelly Holdings LLC recalled Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical… - a moderate-severity action.
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical… was recalled by Cascade Kelly Holdings LLC in August 11, 2021. Reason: CGMP Deviations: Does not meet monograph for denaturant.. Check the official notice for the remedy. Verify recall #D-0697-2021 with the FDA Drug before acting.
The recall
Cascade Kelly Holdings LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: Does not meet monograph for denaturant..
- Moderate
- severity level
- Class II
- classification
- August 11, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0697-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0697-2021) was formally reported on August 11, 2021, with the manufacturer initiating the action on June 30, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Cascade Kelly Holdings LLC is listed as the recalling firm, operating out of Clatskanie, OR. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: CGMP Deviations: Does not meet monograph for denaturant. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
CGMP Deviations: Does not meet monograph for denaturant.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0697-2021 |
| Date reported | August 11, 2021 |
| Date initiated | June 30, 2021 |
| Recalling firm | Cascade Kelly Holdings LLC |
| Firm location | Clatskanie, OR |
| Affected scope | Not disclosed |
| 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. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0697-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cascade Kelly Holdings LLC.
Why was this product recalled? ▼
CGMP Deviations: Does not meet monograph for denaturant.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 11, 2021. Severity: Moderate. Recall number: D-0697-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0697-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 11, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.