Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ESTRONE USP Recalled by American Pharmaceutical Ingredients LLC Due to cGMP Deviations; lack of quality assurance.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Pharmaceutical Ingredients LLC directly.
Affected Products
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Quantity: 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
Why Was This Recalled?
cGMP Deviations; lack of quality assurance.
Where Was This Sold?
This product was distributed to 6 states: CA, GA, KY, NV, NY, TX
About American Pharmaceutical Ingredients LLC
American Pharmaceutical Ingredients LLC has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report