Severity
Moderate
FDA Drug recall · Reported November 26, 2025
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC recalled DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) pe… - a moderate-severity action.
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) pe… was recalled by DermaRite Industries, LLC in November 26, 2025. Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.. Check the official notice for the remedy. Verify recall #D-0162-2026 with the FDA Drug before acting.
The recall
DermaRite Industries, LLC issued this moderate-severity FDA Drug recall-CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated..
Sourced from official FDA Drug enforcement records. Verify recall #D-0162-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0162-2026) was formally reported on November 26, 2025, with the manufacturer initiating the action on August 27, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. DermaRite Industries, LLC is listed as the recalling firm, operating out of North Bergen, NJ. Federal records list the affected scope as 1,480 packets.
The documented reason for this recall is: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1,480 packets
Related Recalls
6
3 from same agency
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.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0162-2026 |
| Date reported | November 26, 2025 |
| Date initiated | August 27, 2025 |
| Recalling firm | DermaRite Industries, LLC |
| Firm location | North Bergen, NJ |
| Affected scope | 1,480 packets |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.