Remedy Gel
Recalling Firm / Manufacturer: Island Kinetics, Inc. d.b.a. CoValence Laboratories
(Chandler, AZ, United States)
FDA Recall Number: D-0480-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
Remedy Gel
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
1060 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent Drug
Full Product Description
Packaging specifications and labeling details
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Terminated
FDA Enforcement Report Date
April 22, 2026
Firm Initiation Date
March 18, 2026
FDA Classification Date
Apr 14, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot 4155D2, 4155D3; Exp. 05/15/2026
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0480-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC