Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
DermaFungal
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Affected NDCs
61924-0234-04
61924-0234-05
Compare with the code on your package — it is the most precise check available.
Drug: Miconazole
- Recalling firm
- DermaRite Industries, LLC
- NDC code
- 61924-234-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0162-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Miconazole recalls
See all
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
Other recalls by DermaRite Industries, LLC
All 2025 recalls
Class II · Moderate risk
UltraSure Anti-Perspirant & Deodorant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
San-E-Foam
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew Skin Repair Cream
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew PeriProtect
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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