CLASS II ONGOING Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Medline Remedy Clinical Treat Antifungal Cream recalled
Medline Industries LP - Northfield is recalling Medline Remedy Clinical Treat Antifungal Cream, 2% Miconazole Nitrate, Paraben Free tube, distributed nationwide in the US. The recall was initiated on 10 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-0315-2024
- FDA event ID
- 93846
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Brand
- Medline
- Manufacturer
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jan 2024
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Jan 2024 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +27 days |
| 14 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Product as listed by the FDA
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Which lots are affected?
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
Where was it sold?
Nationwide in the USA
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 26 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 Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
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| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
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Other Miconazole recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clinical Treat Antifungal Powder, Vanilla Scent tube recalledRemedy Antifungal | Medline Industries LP - Northfield | Potency & Assay | Nationwide |
| Drug | CLASS III | Monistat 1 Simple Cure (Miconazole Nitrate Vaginal Insert) recalledMonistat 1 Combination Pack | Medtech Products | Other | Nationwide |
| Drug | CLASS II | Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL recalled | Lowlite Investments | Sterility | Nationwide |