The Recall Desk
ModerateFDA (Drugs)·D-0162-2026·Announced 2025-11-26

Antifungal Cream Recall Due to Manufacturing Facility Contamination

DermaFungal Antifungal Cream is being recalled because it was manufactured at a facility with CGMP violations and confirmed contamination of other products. The recall affects all lots distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall based on manufacturing facility contamination and CGMP deviations. No illnesses or injuries have been reported, and the recall is precautionary based on facility conditions rather than confirmed contamination of the specific product.

Plain-English summary

DermaFungal Antifungal Cream with 2% Miconazole Nitrate, available in 5 gram packets (NDC 61924-234-05) and 106 gram tubes (NDC 61924-234-04), is being recalled nationwide.

The recall was issued due to a Current Good Manufacturing Practice (CGMP) deviation at the manufacturing facility. Other products and lots produced at the same facility have been found to be contaminated, raising concerns about the safety of all products manufactured there.

The recall affects approximately 1,480 packets with expiration dates on or before August 2027. The product is distributed nationwide across the United States.

Consumers who have purchased DermaFungal Antifungal Cream should stop using it and consult with their healthcare provider if they have concerns about exposure.

The recalled product

Product
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.
Manufacturer
DermaRite Industries, LLC
Category
Drug — Topical
Hazard
  • manufacturing-defect
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots on or before expiry date 08/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category