Class III · Low risk
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
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
Estradiol 12.5 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Estradiol 3 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Estradiol Valerate 40mg/Ml
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Estradiol Valerate 20mg/Ml
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Estradiol Valerate 10mg/Ml
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Estradiol Cypionate 10 Mg/Ml
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Estradiolval 3mg/Test Cyp 35mg/ Test Prop 35mg/Ml W/Pres.
Lack of Assurance of Sterility
Class II · Moderate risk
All estradiol Products
Lack of Processing Controls
Class II · Moderate risk
Estradiol cypionate/Test cyprionate
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Dep-Estradiol 10 mg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol USP 99.5%
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class II · Moderate risk
Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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