Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Estradiol recalled?

Yes — there is an active recall. 23 ongoing FDA recalls mention Estradiol (295 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Estradiol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Estradiol recalls on record

none so far in 2026; 295 on record, newest first
Class II · Moderate risk

Estradiol 8 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1476-2015
Class II · Moderate risk

Estradiol 6 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1475-2015
Class II · Moderate risk

Estradiol 50 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1474-2015
Class II · Moderate risk

Estradiol 4 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1473-2015
Class II · Moderate risk

Estradiol 3 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1472-2015
Class II · Moderate risk

Estradiol 25 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1471-2015
Class II · Moderate risk

Estradiol 22 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1470-2015
Class II · Moderate risk

Estradiol 20 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1469-2015
Class II · Moderate risk

Estradiol 18 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1468-2015
Class II · Moderate risk

Estradiol 15 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1467-2015
Class II · Moderate risk

Estradiol 12.5 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1466-2015
Class II · Moderate risk

Estradiol 100 mg

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1465-2015
Class II · Moderate risk

Estradiol 10 mg Sterile Pellet

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1464-2015
Class II · Moderate risk

Bi-Est (estriol,estradiol)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1415-2015
Class II · Moderate risk

Bi-Est (estriol,estradiol)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1414-2015
Class II · Moderate risk

Estradiol cream

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1413-2015