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.
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP deviations- Lack of Quality Assurance
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
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