American Pharmaceutical Ingredients ESTRONE USP Bottles Recall: Quality Assurance Issues
American Pharmaceutical Ingredients LLC recalls ESTRONE USP 1g, 5g, and 25g bottles (NDCs 58597-8049-2, 58597-8049-3, 58597-8049-4) due to cGMP deviations and lack of quality assurance. These prescription compounding products were sold with specific lot numbers and expiration dates.
Recall notice
cGMP Deviations; lack of quality assurance.
Contact the company
What happened, in plain English
American Pharmaceutical Ingredients LLC is recalling ESTRONE USP medication bottles (1g, 5g, and 25g) because of quality control issues during manufacturing. This recall affects prescription compounding products that were sold with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/41751-american-pharmaceutical-ingredients-estrone-usp-bottles-recall-quality-assurance-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41751-american-pharmaceutical-ingredients-estrone-usp-bottles-recall-quality-assurance-issues · Updated October 8, 2026 · FDA enforcement record: FDA #D-0919-2017
Cite this page
“American Pharmaceutical Ingredients ESTRONE USP Bottles Recall: Quality Assurance Issues.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41751-american-pharmaceutical-ingredients-estrone-usp-bottles-recall-quality-assurance-issues. Based on FDA recall #D-0919-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0919-2017%22&limit=1).
Why it’s dangerous
The recall is due to cGMP deviations and lack of quality assurance in the manufacturing process. This means the medication may not meet the required standards for safety and effectiveness, potentially leading to issues with the product's quality.
Who’s affected
Prescription compounding patients and healthcare providers who use ESTRONE USP medication bottles with the listed NDC numbers and lot numbers are affected. Those who have the specific bottles with the mentioned expiration dates are at risk.
How to tell if you have this one
Check for ESTRONE USP bottles labeled with NDC numbers 58597-8049-2 (1g), 58597-8049-3 (5g), or 58597-8049-4 (25g). The product was sold with specific lot numbers and an expiration date of May 5, 2017.
- Brand
American Pharmaceutical Ingredients- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC number on the bottle to confirm if it matches the recalled products (58597-8049-2, 58597-8049-3, or 58597-8049-4).
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “NY, GA, NV, CA, KY, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Georgia, Kentucky, Nevada, New York, Texas.
Recall timeline
FDA terminated this recall 13 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.
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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-0919-2017 (April 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0919-2017 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.