Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Estrone USP for prescription compounding Recalled by American Pharmaceutical Ingredients LLC Due to CGMP Deviations: Lack of stability data and controls...
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 for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Quantity: 5000 g
Why Was This Recalled?
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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