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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
Medications & Supplements/Topical Products

Medline Remedy Antifungal Cream Recalled for Containing Parabens

Agency Publication Date: February 6, 2024
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Summary

Medline Industries, LP is recalling 1,786 tubes of Medline Remedy Clinical TREAT Antifungal Cream (2% miconazole nitrate). The product labeling incorrectly claims the cream is "Paraben Free," but it actually contains parabens as part of its formulation. This recall affects the 4 FL OZ (118 mL) tubes distributed nationwide.

Risk

Consumers who have sensitivities or allergies to parabens may experience skin irritation or allergic reactions if they use this product believing it to be free of those ingredients. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Medline Remedy Clinical TREAT Antifungal Cream (2% Miconazole Nitrate) sold in 4 FL OZ (118 mL) tubes with NDC 53329-147-44.
  2. Identify affected products by looking for lot numbers 08926, 08926A with an expiration date of 8/2025, or 08928 with an expiration date of 9/2025 printed on the tube.
  3. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Medline Industries, LP for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate (4 FL OZ)
Variants: 2% Miconazole Nitrate, 4 FL OZ (118 mL) tube
Lot Numbers:
08926
08926A (Exp. 8/2025)
08928 (Exp. 9/2025)
NDC:
53329-147-44

Recall #: D-0315-2024; Quantity: 1,786 tubes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93846
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 1,786 tubes
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.