Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Is Miconazole recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Miconazole (18 total). Check the affected lots below.
Most common reason: Chemical / undeclared (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Miconazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Miconazole recalls in 2026
1 initiated in 2026, 18 in total — newest first
Class II · Moderate risk
DermaFungal
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Medline Remedy Clinical TREAT Antifungal Cream
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.
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class II · Moderate risk
Clinical TREAT Antifungal Powder
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Class II · Moderate risk
Lotrimin AF
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Miconazole 7 2% 45gm Apl
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
CGMP Deviations
Class III · Low risk
Zeasorb AF
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Class III · Low risk
Monistat 1 Simple Cure
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Class II · Moderate risk
Miconazole Nitrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Miconazole 3% Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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