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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Personal Care & Cosmetics/Oral Care

OralProCare and Den-Mat Oral Care Products Recalled for Manufacturing Deviations

Agency Publication Date: January 31, 2024
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Summary

Den-Mat Holdings, LLC has issued a voluntary recall for approximately 10,447 units of OralProCare medicated lip treatment and Hydrogen Peroxide Oral Rinse. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, meaning the products may not meet their labeled quality specifications. The affected items include 344 tubes of medicated lip treatment and 10,103 units of various sizes of oral rinse distributed nationwide in the United States.

Risk

Manufacturing deviations can result in products that do not contain the correct amount of active ingredients or may have unknown quality issues, potentially reducing the effectiveness of the treatment or causing unexpected side effects.

What You Should Do

  1. This recall affects OralProCare medicated lip treatment (9.9 g tube) and Hydrogen Peroxide Oral Rinse in 16 fl. oz., 64 fl. oz., and 128 fl. oz. bottles.
  2. For the OralProCare lip treatment, check your packaging for NDC 59883-500-01 and UPC 359883000004 with lot numbers 2319500023 or 2330400002.
  3. For the Hydrogen Peroxide Oral Rinse, check your packaging for NDCs 59883-202-16, 59883-202-64, or 59883-202-28. See the Affected Products section below for the full list of affected codes.
  4. If you have health concerns regarding the use of these products, contact your healthcare provider or pharmacist.
  5. Return any unused product to the place of purchase for a refund, throw it away, or contact Den-Mat Holdings, LLC directly for further instructions.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: OralProCare medicated lip treatment (9.9 g)
Variants: Ethyl alcohol 6.0%
UPC Codes:
359883000004
Lot Numbers:
2319500023 (Exp: 01- 12-2024)
2330400002 (Exp: 11-02-2024)
NDC:
59883-500-01

Recall #: D-0286-2024; Quantity: 344 tubes

Product: Hydrogen Peroxide Oral Rinse (16 fl. oz.)
Variants: Fresh Mint Flavor, Alcohol Free, 16 fl. oz. (473 mL)
UPC Codes:
3598830000097
Lot Numbers:
2214500032 (Exp. 02/05/2024)
2216700041 (Exp. 02/05/2024)
2301900118 (Exp. 02/05/2024)
2312600002 (Exp. 02/05/2024)
2204800002 (Exp. 02/05/2024)
2306100034 (Exp. 02/22/2024)
2322000078 (Exp. 02/22/2024)
2322200021 (Exp. 02/22/2024)
2318000026 (Exp. 02/24/2024)
2323000070 (Exp. 08/29/2025)
2324400005 (Exp. 08/29/2025)
2323300016 (Exp. 08/29/2025)
2324800079 (Exp. 08/30/2025)
2325800008 (Exp. 09/18/2025)
2328600011 (Exp. 10/10/2025)
2328600032 (Exp. 10/10/2025)
2324800123 (Exp. 10/11/2025)
2329700005 (Exp. 10/19/2025)
2329700090 (Exp. 10/19/2025)
2330400003 (Exp. 10/25/2025)
2334100101 (Exp. 11/13/2025)
2335300019 (Exp. 12/19/2025)
2335400038 (Exp. 12/19/2025)
NDC:
59883-202-16

Recall #: D-0287-2024

Product: Hydrogen Peroxide Oral Rinse (64 fl. oz.)
Variants: Fresh Mint Flavor, Alcohol Free, 64 fl. oz. (1.89 L)
Lot Numbers:
2212200014 (Exp 02/22/2024)
2323300017 (Exp 08/29/2025)
2324800124 (Exp 09/18/2025)
NDC:
59883-202-64

Recall #: D-0287-2024

Product: Hydrogen Peroxide Oral Rinse (128 fl. oz.)
Variants: Fresh Mint Flavor, Alcohol Free, 128 fl. oz. (1 gal) 3.78L
UPC Codes:
3598830000073
Lot Numbers:
2211100001 (Exp 02/24/2024)
2330500009 (Exp 10/25/2025)
2333200014 (Exp 12/19/2025)
NDC:
59883-202-28

Recall #: D-0287-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93831
Status: Active
Manufacturer: Den-Mat Holdings, LLC
Sold By: Nationwide distributors
Manufactured In: United States
Units Affected: 2 products (344 tubes; 10,103 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.