The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0287-2024·Announced 2024-02-07

Hydrogen Peroxide Oral Rinse Recalled for Manufacturing Deviations

Den-Mat Holdings recalls Hydrogen Peroxide Oral Rinse products nationwide due to manufacturing deviations that may result in products not conforming to labeled specifications.

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: FDA Class II recall with no reported illnesses or injuries and a manufacturing compliance issue that is precautionary in nature. The hazard is theoretical—products may not meet specifications—rather than a known safety incident.

Plain-English summary

Den-Mat Holdings, LLC is recalling Hydrogen Peroxide Oral Rinse in three sizes (16 fl. oz., 64 fl. oz., and 128 fl. oz. bottles) with Fresh Mint Flavor and alcohol-free formula, manufactured in Lompoc, California.

The recall is being issued due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. These deviations may result in products not conforming to their labeled specifications.

Approximately 10,103 units were distributed nationwide in the United States. Multiple lot numbers are affected, with expiration dates spanning from February 2024 through December 2025. Consumers who have purchased affected products should stop using them and consult their healthcare provider or dentist if they have any questions.

The recalled product

Product
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…
Manufacturer
Den-Mat Holdings, LLC
Category
Drug — Oral Rinse
Hazard
Affected units
10,103

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 (20)

  • Lot #: a) 2214500032
  • 2216700041
  • 2301900118
  • 2312600002
  • 2204800002
  • Exp. 02/05/2024
  • 2306100034
  • 2322000078
  • 2322200021 02/22/2024
  • 2318000026
  • Exp 02/24/2024
  • 2323000070
  • 2324400005
  • 2323300016
  • Exp 08/29/2025
  • 2324800079
  • Exp 08/30/2025
  • 2325800008
  • Exp 09/18/2025
  • 2328600011

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Den-Mat 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 · Den-Mat Holdings, LLC

See all →

Same hazard · non conformance

See all →

Other drug recalls

Similar recalls