Medline Remedy Clinical TREAT Antifungal Cream recall
FDA recall D-0315-2024 · initiated Jan 10, 2024
MEDLINE INDUSTRIES, LP - Northfield recalled Medline Remedy Clinical TREAT Antifungal Cream in Jan 2024 — an FDA Class II recall (D-0315-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
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: 1,786 tubes
Details
- Product
- 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
- Recalling company
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 10, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was Medline Remedy Clinical TREAT Antifungal Cream recalled?
- MEDLINE INDUSTRIES, LP - Northfield recalled Medline Remedy Clinical TREAT Antifungal Cream in Jan 2024 — an FDA Class II recall (D-0315-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Medline Remedy Clinical TREAT Antifungal Cream recalled?
- Per the FDA enforcement record, the reason for recall D-0315-2024 was: 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.
- Is a recalled Medline Remedy Clinical TREAT Antifungal Cream 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 Medline Remedy Clinical TREAT Antifungal Cream are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025. 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-0315-2024.