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FDA Drug Verify with FDA Drug → Moderate Class II Ongoing

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.

Reported: February 7, 2024 Initiated: January 16, 2024 #D-0287-2024 10,103 units units

The recall

Den-Mat Holdings, LLC issued this moderate-severity FDA Drug recall — CGMP Deviations: products may not conform to the labeled specifications..

Moderate
severity level
10,103 units
units affected
Class II
classification
February 7, 2024
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0287-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0287-2024) was formally reported on February 7, 2024, with the manufacturer initiating the action on January 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Den-Mat Holdings, LLC is listed as the recalling firm, operating out of Lompoc, CA. Federal records indicate 10,103 units units are affected.

The documented reason for this recall is: CGMP Deviations: products may not conform to the labeled specifications. Distribution data in the federal record shows the product reached: Nationwide in the US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Where this recall sits in the database

Severity2119858883High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.

Severity

Moderate

Units Affected

10,103 units

Related Recalls

6

0 from same agency

Product Description

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.

Reason for Recall

CGMP Deviations: products may not conform to the labeled specifications.

Details

Recalling Firm
Den-Mat Holdings, LLC
Units Affected
10,103 units
Distribution
Nationwide in the US
Location
Lompoc, CA

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number D-0287-2024
Date reported February 7, 2024
Date initiated January 16, 2024
Recalling firm Den-Mat Holdings, LLC
Units affected 10,103 units
Distribution Nationwide in the US

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

10,103 units units affected — limited or regional distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.. Recalled by Den-Mat Holdings, LLC. Units affected: 10,103 units.
Why was this product recalled?
CGMP Deviations: products may not conform to the labeled specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0287-2024.
Where was the recalled product distributed?
Distribution: Nationwide in the US.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0287-2024) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

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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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported February 7, 2024.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).