CLASS III Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone recalled
Island Kinetics, Inc. d.b.a. CoValence Laboratories is recalling Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, distributed nationwide in the US. The recall was initiated on 18 Mar 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0481-2026
- FDA event ID
- 98624
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories, Chandler, AZ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Mar 2026
- FDA classified
- 14 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Mar 2026 | Recall initiated by company | |
| 14 Apr 2026 | Classified by FDA | +27 days |
| 22 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot 4212D2; Exp. 07/03/2026
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98624This product is part of a recall event; the main page for the event is Remedy Gel, hydrocortisone 1% recalled by Island Kinetics, Inc. d.b.a..
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Remedy Gel, hydrocortisone 1% recalled by Island Kinetics, Inc. d.b.a. | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Potency & Assay | Nationwide | |
| CLASS III | Essential Calming Skin Gel, hydrocortisone recalled | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Potency & Assay | Nationwide |