CLASS II ONGOING Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
Hydrogen Peroxide Oral Rinse recalled by Den-Mat Holdings
Den-Mat Holdings is recalling Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol, distributed nationwide in the US. The recall was initiated on 16 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0287-2024
- FDA event ID
- 93831
- Recalling firm
- Den-Mat Holdings, Lompoc, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2024
- FDA classified
- 31 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 16 Jan 2024 | Recall initiated by company | |
| 31 Jan 2024 | Classified by FDA | +15 days |
| 7 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products may not conform to the labeled specifications.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Is Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol recalled?
Yes. Den-Mat Holdings recalled Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol on 16 Jan 2024. The recall is Class II and its status is Ongoing. Recall number D-0287-2024.
Why was it recalled?
CGMP Deviations: products may not conform to the labeled specifications.
Which lots are affected?
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, 2328600032, 10/10/2025; 2324800123, Exp 10/11/2025; 2329700005, 2329700090, Exp 10/19/2025; 2330400003, Exp 10/25/2025; 2334100101, Exp 11/13/2025; 2335300019, 2335400038, Exp 12/19/2025. b) 2212200014, Exp 02/22/2024; 2323300017, Exp 08/29/2025; 2324800124, Exp 09/18/2025. c) 2211100001, Exp 02/24/2024; 2330500009, Exp 10/25/2025; 2333200014, Exp12/19/2025.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Den-Mat Holdings
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | OralProCare medicated lip treatment recalled by Den-Mat Holdings | Den-Mat Holdings | Manufacturing (CGMP) Deviations | Nationwide |
Other Hydrogen peroxide recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | [Correct Front Panel] Hydrogen Peroxide Topical Solution recalledHydrogen Peroxide | Consumer Product Partners | Packaging Defects | VA |
| Drug | CLASS II | Hydrogen Peroxide Topical Solution USP, 3% (1 PT) recalled by Vi-JonHydrogen Peroxide | Vi-Jon | Packaging Defects | Nationwide |
| Drug | CLASS II | Hydrogen Peroxide Topical Solution recalled by Vi-JonHydrogen Peroxide | Vi-Jon | Packaging Defects | Nationwide |
| Drug | CLASS II | Hydrogen Peroxide Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |