FDA Drug recall D-0392-2016
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 105…
- FDA Drug
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 105… by Geritrex, citing marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0392-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-27 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Geritrex |
| Distribution | US |
Product
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
Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Identifiers
| code_info | Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081,…Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15026752, 15046752, 15066752, 15066753 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.