Fagron Estrone Bottles Recall: C G M P Quality Issues
Fagron recalls Estrone prescription compounding bottles due to quality assurance failures at the API manufacturer. Affected bottles have specific NDC codes and expiration dates.
Lower-risk recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
Contact the company
What happened, in plain English
Fagron is recalling Estrone prescription compounding bottles because the manufacturer failed quality control checks. This could lead to unsafe drug products if used without proper quality assurance. Read more at govinfonow.com/recall/41760-fagron-estrone-bottles-recall-c-g-m-p-quality-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41760-fagron-estrone-bottles-recall-c-g-m-p-quality-issues · Updated October 8, 2026 · FDA enforcement record: FDA #D-0792-2017
Cite this page
“Fagron Estrone Bottles Recall: C G M P Quality Issues.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41760-fagron-estrone-bottles-recall-c-g-m-p-quality-issues. Based on FDA recall #D-0792-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0792-2017%22&limit=1).
Why it’s dangerous
The recall is due to quality assurance failures at the API manufacturer, meaning the drug may not meet safety and quality standards. This could result in ineffective or harmful medication if used without proper quality control.
Who’s affected
Prescription compounding pharmacies and healthcare providers who use Estrone for medical purposes. Patients receiving this medication under a doctor's supervision are not directly affected.
How to tell if you have this one
Check for Estrone prescription compounding bottles with NDC codes 51552-0445-1, 51552-0445-2, 51552-0445-4, or 51552-0445-5. Also look for Estrone USP bottles with NDC codes 52372-9494-01, 52372-9494-05, 52372-9494-03, or 52372-9494-02.
- Brand
Fagron- Category
Drug
All 2 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 in US and PR and Australia
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0791-2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011; Lot #, Expiration Date: a) 1 G bottle: 16D08-U02-030005, Exp. 3/6/2018; 16F23-U05-033657, Exp. 5/26/2018; 17C02-U02-035889, Exp. 1/19/2019. b) 5 G bottle: 16D08-U02-030004, 16D08-U02-032486, Exp. 3/6/2018; 16F23-U05-033656, 16F23-U05-035093, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16D08-U02-030003, 16D08-U02-032475, Exp. 3/6/2018; 16F23-U05-033655, 16F23-U05-035092, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 16D08-U02-030002, 16D08-U02-032474, Exp. 3/6/2018; 16F23-U05-031158,16F23-U05-033654, 16F23-U05-035091,16G18-F002, Exp. 5/26/2018; 17C02-U02-035888, Exp. 1/19/2019. | 15283 grams |
| D-0792-2017 | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547; Lot #, Expiration Date: a) 16J05-U01-032346, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033898, Exp. 5/18/2018. b) 16F23-U04-031011, 16J05-U02-032345, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033897, 16J25-U05-034708, 16J25-U05-035527, Exp. 5/18/2018; c) 16F23-U04-031024, 16K16-U337-033665, 16G18-F003; 16G18-F003A, Exp. 5/17/2018. d) 16K16-U337-033664, 16G18-F003, Exp. 5/17/2018; 16J25-U05-034707, Exp. 5/18/2018. | 1313 grams |
What to do — step by step
Check Product Labels
Look for specific NDC codes and expiration dates listed in the recall notice to confirm if your bottle is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide in US and PR and Australia” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 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.
Contact Fagron
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0792-2017 — Fagron Estrone Bottles Recall: C G M P Quality Issues Hello, I own a Fagron Estrone Bottles Recall: C G M P Quality Issues that is covered by recall D-0792-2017 from Fagron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0792-2017 (April 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0792-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.