FDA recall, , Low risk
CoValence Laboratories Hydrocortisone Gels and Balm
Remedy Gel, hydrocortisone 1%, is subpotent.
Recall ended Jun 17, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Island Kinetics, Inc. d.b.a. CoValence Laboratories, of Chandler, Arizona, recalled three hydrocortisone 1% products because they are subpotent. The products are Remedy Gel, Essential Calming Skin Gel, and Skin Rehab, distributed nationwide. The company began the recall on March 18, 2026, and the FDA added it to its Enforcement Report on April 14, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
3 products
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle
- NDC
- 66915-531-04
- Lot code
- 4212D2
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle
- NDC
- 66915-531-12
- Lot code
- 4155D2
- 4155D3
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar
- NDC
- 66915-531-05
- Lot code
- 4212D4
From the FDA notice
NDC 66915-531-12; 66915-531-13
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Island Kinetics, Inc. d.b.a. CoValence LaboratoriesChandler, Arizona
- Hazard
- Wrong drug strength
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98624
- Recall numbers
- D-0480-2026 to D-0482-2026
All recalls from Island Kinetics, Inc. d.b.a. CoValence Laboratories
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Recall ended
Archived
Summary updated
