Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories Recalled by Geritrex Corp Due to Marketed without an Approved NDA/ANDA: FDA has determined...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Geritrex Corp directly.
Affected Products
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Quantity: 844,704 suppositories
Why Was This Recalled?
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Geritrex Corp
Geritrex Corp has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report