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Estradiol

FDA recalls

15 rows

DateCompany and reasonClass
May 11, 2026Ani Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full.		Class II · Ongoing
May 15, 2024Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.		Class III · Ongoing
Feb 20, 2023Padagis US LLC
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 III · Ongoing
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		Class II · Terminated
Apr 15, 2021Noven Pharmaceuticals Inc
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 · Terminated
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated
Oct 21, 2019Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.		Class II · Terminated
Jun 2, 2019Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.		Class II · Terminated
Dec 25, 2018Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator		Class II · Terminated
Sep 6, 2018Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.		Class II · Terminated
May 3, 2018Noven Pharmaceuticals, Inc.
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 · Terminated
Mar 18, 2018Teva Pharmaceuticals USA
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.		Class II · Terminated
Feb 25, 2018Paddock Laboratories, LLC.
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 · Terminated
Apr 26, 2017Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.		Class III · Terminated
Feb 24, 2015Noven Pharmaceuticals, Inc.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).