Antifungal cream recalled over contamination found at the same manufacturing facility
DermaRite Industries is recalling 1,480 packets of DermaFungal antifungal cream because it was made at the same facility where other products and lots were found contaminated.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 as a precautionary recall: the record cites contamination found elsewhere in the facility rather than confirmed contamination of these lots or any reported harm.
Plain-English summary
DermaFungal Antifungal Cream with 2% Miconazole Nitrate, in 5 g packets (NDC 61924-234-05) and 106 g tubes (NDC 61924-234-04), from DermaRite Industries of North Bergen, New Jersey, is being recalled for a CGMP deviation.
The recall follows the product being manufactured at the same facility where other products and lots were found to be contaminated.
The recall covers 1,480 packets across all lots with an expiry date on or before August 2027. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record cites facility association rather than confirmed contamination of these lots, and reports no illnesses. Anyone holding an affected product should follow the firm's instructions.
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
- Affected units
- 1,480
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.
Part of a larger recall action
This product is one of 18 recalled by DermaRite Industries, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · DermaRite Industries, LLC
See all →- ModeratePetrolatum barrier ointment recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateAlcohol hand foam recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateAntiperspirant spray recalled over contamination found elsewhere at the facility
FDA (Drugs) · 2025-11-26
- ModerateMoisturizing skin cream recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateSkin protectant ointment recalled over contamination found at its manufacturing facility
FDA (Drugs) · 2025-11-26
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateAntifungal Cream Recalled for Manufacturing Deviations
FDA (Drugs) · 2025-05-28
- CriticalHealth care antiseptic recalled over contamination with Burkholderia cepacia bacteria
FDA (Drugs) · 2025-09-10
- ModerateMedline Antifungal Cream Recalled for False Paraben-Free Labeling
FDA (Drugs) · 2024-02-14
- LowNovartis Recalls Lamisil AT Antifungal Cream Due to Illegible Labeling
FDA (Drugs) · 2013-05-29
- ModerateAntifungal Powder Recalled Due to Low Active Ingredient Content
FDA (Drugs) · 2023-11-15
- ModerateMed Pride clotrimazole antifungal cream recalled over manufacturing practice deviations
FDA (Drugs) · 2026-06-24