Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Estrone Recalled by Fagron, Inc Due to cGMP Deviations: lack of quality assurance at the...
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 Fagron, Inc directly.
Affected Products
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
Quantity: 1313 grams
Why Was This Recalled?
cGMP Deviations: lack of quality assurance at the API manufacturer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fagron, Inc
Fagron, Inc has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report