Class II U.S. Food and Drug Administration

DermaRite Industries, LLC DermaFungal, Antifungal Cream with 2% Miconazole Nitrate recall: CGMP Deviation; manufactured at the same facility where other products

Recall published 11 months ago

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0162-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
DermaRite Industries, LLC
Product type
Prescription & OTC drugs
Units affected
1,480 packets
Distribution
Nationwide
Made in
United States
Lot / code info
All lots on or before expiry date 08/2027

Products covered by this recall

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.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2027 — 1
  • 480 packets

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 2027 — 1
  • 480 packets

NDC number

On the carton and again on the bottle or blister label.

  • 61924-234-05
  • 61924-234-04

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.18 oz
  • 3.75 oz

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

DermaRite Industries, LLC — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  3. Return the affected pack to the pharmacy for a replacement from a good lot.
  4. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: DermaRite Industries, LLC — 7777 W Side Ave, North Bergen, NJ, 07047-6436

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was DermaRite Industries, LLC prescription & otc drugs recalled?

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2027 — 1, 480 packets; best-by date 08 or 2027 — 1. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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