What does Class III mean?

Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.

Is this recall still active?

The FDA lists the recall as terminated (closed 06/17/2026). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIIDrug recallTerminated

Remedy Gel, hydrocortisone 1% recall

Recalled by Island Kinetics, Inc. d.b.a. CoValence Laboratories of Chandler, AZ · FDA report 04/22/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class III; Low risk
Status: Terminated; Closed 06/17/2026
Recall started: 03/18/2026
Distribution: Nationwide

Reason for recall

Subpotent Drug

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

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
Lot and code info: Lot 4155D2, 4155D3; Exp. 05/15/2026
Quantity: 1060 bottles
Recall number: D-0480-2026
Event ID: 98624
Initiated by: Voluntary: Firm initiated

Where it was distributed

U.S. Nationwide

Nationwide

Recall timeline

03/18/2026Firm started the recall
04/14/2026FDA classified it as Class III
04/22/2026Published in the FDA enforcement report
06/17/2026FDA closed (terminated) the recall

All products in this recall

3 products under event 98624

D-0480-2026Remedy 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 This page
D-0481-2026Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport...
D-0482-2026Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261...

More recalls from Island Kinetics, Inc. d.b.a. CoValence Laboratories

Frequently asked questions

Why was Remedy Gel, hydrocortisone 1% recalled?: Subpotent Drug
What does Class III mean?: Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?: U.S. Nationwide
Is this recall still active?: The FDA lists the recall as terminated (closed 06/17/2026). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 04/22/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class III
Status: Terminated
Type: Drug
Reported: 04/22/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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