Class II · Moderate risk
Estradiol 12.5mg pellet
Lack of Assurance of Sterility
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 10mg pellet
Lack of Assurance of Sterility
Class III · Low risk
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk
Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class III · Low risk
ESTRADIOL 20mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk
Estradiol 55 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 50 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 40 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 35 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 25 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 20 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 15 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 12.5 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 10 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class II · Moderate risk
Evamist (estradiol transdermal spray)
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Class II · Moderate risk
Estradiol Hemihydrate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Estradiol USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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