Estradiol recalls

Estradiol products have been recalled 7 times, most recently on 27 May 2026. The recalling company is usually Zydus Pharmaceuticals. The most common reason is potency & assay.

Total recalls7since 2018

Last 12 months1reported

Class I00% of total

Ongoing3latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 71%Class III 2 29%

Why estradiol is recalled

Companies

Product types

Hormones & Birth Control7100%

By year

2026114%
2024343%
2021229%
2018114%

Ongoing estradiol recalls

3 active

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day recalledEstradiol	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day recalledEstradiol	Zydus Pharmaceuticals	Potency & Assay	Nationwide

All estradiol recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day recalledEstradiol	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day recalledEstradiol	Zydus Pharmaceuticals	Potency & Assay	Nationwide
3 Jan 2024Drug	CLASS II	Estradiol Tablets USP, 0.5MG, Tx Only recalled by Cardinal HealthcareEstradiol	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Estradiol Transdermal System, USP 0.1 mg/day recalled by Cardinal HealthEstradiol	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
28 Apr 2021Drug	CLASS II	Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box recalledEstradiol	Noven Pharmaceuticals	Potency & Assay	Nationwide
28 Mar 2018Drug	CLASS II	Estradiol Vaginal Inserts, USP 10 mcg recalled by Teva Pharmaceuticals UEstradiol	Teva Pharmaceuticals USA	Packaging Defects	PR

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.