Class II · Moderate risk
Levonorgestrel and Ethinyl Estradiol Tablets USP
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
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 III · Low risk
Bekyree
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class III · Low risk
Tri-Lo-Marzia
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk
Estradiol Vaginal Inserts USP
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class II · Moderate risk
Estradiol tablets
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class II · Moderate risk
S-Estradiol Valerate 40mg/Ml Mdv Inj in Ethyl Oleate
Lack of Assurance of Sterility
Class II · Moderate risk
S-Estradiol Cyp 5mg/Ml Mdv Inj in Sesame Oil
Lack of Assurance of Sterility
Class II · Moderate risk
S-Estradiol Valerate 20mg/Ml Mdv Inj in Ethyl Oleate
Lack of Assurance of Sterility
Class II · Moderate risk
S-Estradiol Cyp 5mg/Ml Mdv Inj in Ethyl Oleate
Lack of Assurance of Sterility
Class I · High risk
Drospirenone and Ethinyl Estradiol Tablets
Failed dissolution specifications : failed results at the 3-month stability time point.
Class II · Moderate risk
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Class II · Moderate risk
Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Estradiol Vaginal Inserts USP 10 mcg
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class II · Moderate risk
Estradiol Cypionate 10 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
Fayosim (levonorgestrel and ethinyl estradiol)
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class II · Moderate risk
Drospirenone and Ethinyl Estradiol Tablets
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class II · Moderate risk
Estradiol Tablets
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class II · Moderate risk
Ortho-Novum 7/7/7
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Ortho-Novum 1/35
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Estradiol 6 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 25mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 18mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 15mg pellet
Lack of Assurance of Sterility
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