FDA-Drug2026-04-22Class IIIMISBRANDING
Island Kinetics Hydrocortisone 1% Balm recalled for subpotent drug content
LABEL MIX UPNationwide distribution
Stop using Island Kinetics Hydrocortisone Balm
Island Kinetics' Skin Rehab Calming Skin Gel with Hydrocortisone 1% (Lot 4212D2, expires 07/03/2026) does not contain the correct amount of active ingredient. The product is weaker than labeled and may not work as intended for skin inflammation or itching.
- Stop using this product if you have Lot 4212D2
- Check your Hydrocortisone Balm bottle for the lot number on the label
- Consult your doctor if you need a replacement or alternative treatment
- Contact Island Kinetics or your retailer for a refund or replacement
Hazard
Subpotent Drug
Sold states
U.S. Nationwide
Affected count
2895 bottles
Manufactured in
460 S Benson Ln Ste 1-3, N/A, Chandler, AZ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2026More Island Kinetics, Inc. d.b.a. CoValence Laboratories recalls
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