Drug FDA Class III Terminated Sub/super-potent
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
Island Kinetics, Inc. d.b.a. CoValence Laboratories Published Apr 22, 2026
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 35/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Island Kinetics, Inc. d.b.a. CoValence Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Subpotent Drug
Hazards
Subpotency · primary
Affected products (1)
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
1060 bottles
Lot codes: 4155D2
Code info: Lot 4155D2, 4155D3; Exp. 05/15/2026
Affected areas
Nationwide
Timeline
- InitiatedMar 18, 2026
- PublishedApr 22, 2026
- TerminatedJun 17, 2026
- Recall number
- D-0480-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.