Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Is Estradiol recalled?
Yes — there is an active recall. 23 ongoing FDA recalls mention Estradiol (295 total). Check the affected lots below.
Most common reason: Sterility / contamination (100 of these recalls)
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 in 2026
11 initiated in 2026, 295 in total — newest first
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Viorele
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
Estradiol Gel
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II · Moderate risk
Empower Pharmacy
Lack of Assurance of Sterility
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Tri-Lo-Sprintec
Failed Dissolution Specifications
Class III · Low risk
Nortrel 7/7/7
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Nortrel (norethindrone and ethinyl estradiol tablets USP)
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class I · High risk
Tydemy
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class II · Moderate risk
Testosterone 3%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Estradiol Cyp/Test Cyp- Ss Oil- 2mg/50mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Estradiol 0.05% OPH Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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