GRx HiCort 25 — Class II drug recall D-0392-2016
Terminated recall by Geritrex Corp, reported 2015-12-09, distributed nationwide. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbr
| Recall number | D-0392-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geritrex Corp, Mount Vernon, NY, United States |
| Recall initiated | 2015-10-27 |
| Classified | 2015-11-27 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 844,704 suppositories |
| Reason classes | labeling, unapproved product |
| NDC | 54162-0015-12 |
| Lot numbers | 1310001, 1310167, 1311013, 1312008, 13J04, 13S02, 1401055, 1402061, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 14A05, 14C01, 14C05, 14C06, 14E02, 15026752, 15046752, 15066752, 15066753 |
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 for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0392-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.