FDA Recall D-0480-2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Chandler, AZ
Class III Ongoing 57 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-0480-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2026-03-18
- Classified by FDA Center
- 2026-04-14
- FDA published
- 2026-04-22
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Firm location
- Chandler, AZ
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.