Fagron Estriol Bottles Recall: Quality Assurance Issues
Fagron recalls prescription estriol bottles due to quality assurance failures at the API manufacturer. This affects specific bottle sizes and lot numbers. Consumers should contact Fagron for details.
Recall notice
cGMP Deviations: lack of quality assurance at the API manufacturer.
Contact the company
What happened, in plain English
Fagron is recalling prescription estriol bottles that were made without proper quality control at the API manufacturer. This recall affects specific bottle sizes and lot numbers, and users should contact Fagron for instructions. Read more at govinfonow.com/recall/41118-fagron-estriol-bottles-recall-quality-assurance-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41118-fagron-estriol-bottles-recall-quality-assurance-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0079-2018
Cite this page
“Fagron Estriol Bottles Recall: Quality Assurance Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41118-fagron-estriol-bottles-recall-quality-assurance-issues. Based on FDA recall #D-0079-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0079-2018%22&limit=1).
Why it’s dangerous
The recall is due to cGMP deviations at the API manufacturer, meaning the product may not meet quality standards. This could lead to inconsistent dosing or other safety concerns for patients using the medication.
Who’s affected
Prescription users of estriol who have the specific bottle sizes and lot numbers listed in the recall. Those with the affected products are at risk due to potential quality issues.
How to tell if you have this one
Check for the specific bottle sizes: 1g, 5g, 25g, or 100g bottles with the listed lot numbers and expiration dates. The product is for prescription use only and distributed by Fagron, Inc.
- Brand
Fagron- Category
Drug
What to do — step by step
Contact Fagron
Reach out to Fagron, Inc. at 1-(800) 423-6967 for specific instructions on what to do with the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months 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-0079-2018 — Fagron Estriol Bottles Recall: Quality Assurance Issues Hello, I own a Fagron Estriol Bottles Recall: Quality Assurance Issues that is covered by recall D-0079-2018 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-0079-2018 (October 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0079-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.