← FDA ENFORCEMENT
D-0480-2026Class III
Island Kinetics, Inc. d.b.a. CoValence Laboratories
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Product type
Drug
Status
Terminated
Report date
2026-04-22
Distribution
U.S. Nationwide
Firm state
AZ
Product quantity
1060 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Subpotent Drug
Product description
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
Code / lot info
Lot 4155D2, 4155D3; Exp. 05/15/2026
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →