Class II · Moderate risk
Estradiol Cypionate 10mg/mL
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
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP)
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Estradiol Tablets USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk
Class III · Low risk
Class III · Low risk
Tydemy
Subpotent Drug
Class II · Moderate risk
Estradiol Valerate 5mg/Ml in Ethyl Oleate 5mg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 50mg/Ml Inj #2 Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 50mg/Ml in Ethyl Oleate Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 40mg/Ml in Ethyl Oleate Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 30mg/Ml Inj #1 in Ethyl Oleate Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 10mg/Ml in Ethyl Oleate 10mg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 5mg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Estradiol Transdermal System Delivers 0.0375 mg/day
Defective Delivery System: Out of specification for release rate testing and 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: Out of specification for release rate testing and 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
Balziva 28 Day
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Estradiol Transdermal System
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Mibelas 24 Fe
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk
Estradiol
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk
Estradiol 1.8 mg capsule 30 cap bottle
Lack of Processing Control
Class II · Moderate risk
Estradiol Vag Cream 0.01% Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube
Lack of Processing Control
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.