Hydrogen Peroxide Oral Rinse recall
FDA recall D-0287-2024 · initiated Jan 16, 2024
Den-Mat Holdings, LLC recalled Hydrogen Peroxide Oral Rinse in Jan 2024 — an FDA Class II recall (D-0287-2024) because CGMP Deviations: products may not conform to the labeled specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: products may not conform to the labeled specifications.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,103 units
Details
- 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 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.
- Recalling company
- Den-Mat
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jan 16, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was Hydrogen Peroxide Oral Rinse recalled?
- Den-Mat Holdings, LLC recalled Hydrogen Peroxide Oral Rinse in Jan 2024 — an FDA Class II recall (D-0287-2024) because CGMP Deviations: products may not conform to the labeled specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Hydrogen Peroxide Oral Rinse recalled?
- Per the FDA enforcement record, the reason for recall D-0287-2024 was: CGMP Deviations: products may not conform to the labeled specifications.
- Is a recalled Hydrogen Peroxide Oral Rinse dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Hydrogen Peroxide Oral Rinse are affected?
- Distributed: Nationwide in the US. The recall covers these lots — 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, Ex…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0287-2024.