Geritrex GRx HiCort 25 Suppository Recall: Unapproved Drug
Geritrex Corp recalls GRx HiCort 25 suppositories because they are marketed without an approved New Drug Application. Check lot numbers for details.
Use caution until it’s fixed
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Contact the company
What happened, in plain English
Geritrex Corporation is recalling GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories in 12-count boxes. The FDA determined these products are unapproved new drugs and misbranded because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the safety and effectiveness of the product have not been formally evaluated by the FDA for this specific marketing. Read more at govinfonow.com/recall/43416-geritrex-corp-recalls-grx-hicort-25-hydrocortisone-acetate-25-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43416-geritrex-corp-recalls-grx-hicort-25-hydrocortisone-acetate-25-mg · Updated October 11, 2026 · FDA enforcement record: FDA #D-0392-2016
Cite this page
“Geritrex GRx HiCort 25 Suppository Recall: Unapproved Drug.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43416-geritrex-corp-recalls-grx-hicort-25-hydrocortisone-acetate-25-mg. Based on FDA recall #D-0392-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2016%22&limit=1).
Why it’s dangerous
The primary risk is that the product lacks FDA approval for marketing, meaning its quality, safety, and efficacy have not been verified through the standard regulatory process. While hydrocortisone acetate is a known medication, using an unapproved version poses uncertainty regarding proper dosage, purity, and labeling accuracy.
Who’s affected
Consumers who purchased GRx HiCort 25 Suppositories distributed nationwide, specifically those with lot numbers including 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15046752, and 15066753.
How to tell if you have this one
Look for a 12-count box of GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories distributed by Geritrex Corporation. Check the NDC number 54162-015-12 and verify if your lot number matches one of the recalled lots listed above.
- Brand
Geritrex- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0390-2016 | Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550; Lot #: a)1502156, 1507104 b)1503039, 1507001 | 9,948 tubes: 3 oz(8,832), 7 oz(1,116) |
| D-0391-2016 | Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15; Lot # 1502078, 1504139 | 1,032 tubes |
| D-0392-2016 | 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; 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 | 844,704 suppositories |
| D-0393-2016 | Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550; Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036 | 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350 |
What to do — step by step
Check Your Lot Number
Verify if your product's lot number is among the recalled lots: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15046752, or 15066753.
Consult Your Doctor
If you have a recalled lot number, contact your healthcare provider to discuss alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0392-2016 (October 27, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0392-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.