FDA Recall D-0482-2026
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
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-0482-2026- 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.