Multi-event March 2026 FDA Recall Drug by Island Kinetics, Inc. D.b.a. Covalence Laboratories

This Multi-event Class III drug recall was voluntarily initiated by Island Kinetics, Inc. D.b.a. Covalence Laboratories on March 18, 2026 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0480-2026 ONGOING D-0482-2026 ONGOING D-0481-2026 ONGOING

Recall Number: D-0480-2026

Reason for Recall
Subpotent Drug
Initiated
03-18-2026
Reported
04-22-2026
Quantity
1060 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98624
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 4155D2, 4155D3; Exp. 05/15/2026

Recall Number: D-0482-2026

Reason for Recall
Subpotent Drug
Initiated
03-18-2026
Reported
04-22-2026
Quantity
299 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98624
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 4212D4; Exp. 07/31/2026

Recall Number: D-0481-2026

Reason for Recall
Subpotent Drug
Initiated
03-18-2026
Reported
04-22-2026
Quantity
2895 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98624
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot 4212D2; Exp. 07/03/2026