Estradiol recalls

The FDA has published 29 recalls involving Estradiol since 2015. The latest was reported on 27 May 2026. Most were for potency & assay. Noven Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls29since 2015

Last 12 months1reported

Class I00% of total

Ongoing4latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 1 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 0 0%Class II 23 79%Class III 6 21%

Why estradiol is recalled

Companies

Brands

By year

202613%
202513%
2024310%
202313%
202227%
2021310%
2019414%
20181034%
201713%
2015310%

Ongoing estradiol recalls

4 active

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Estradiol Gel, 1%, 25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0375mg/day recalledEstradiol	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 025mg/day recalledEstradiol	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
22 Mar 2023Drug	CLASS III	Evamist (estradiol transdermal spray) recalled by Padagis USEvamist	Padagis US	Potency & Assay	Nationwide

All estradiol recalls, newest first

29 total

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	Estradiol Gel, 1%, 25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide
5 Mar 2025Drug	CLASS II	Estradiol Gel, 1%, 25 mg/g, 30 packets recalled by Padagis US	Padagis US	Packaging Defects	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 0375mg/day recalledEstradiol	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 025mg/day recalledEstradiol	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
3 Jan 2024Drug	CLASS II	Estradiol Tablets USP, 5MG, Tx Only recalled by Cardinal HealthcareEstradiol	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS III	Evamist (estradiol transdermal spray) recalled by Padagis USEvamist	Padagis US	Potency & Assay	Nationwide
9 Feb 2022Drug	CLASS III	Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey	Teva Pharmaceuticals U	Labeling Errors	Nationwide
9 Feb 2022Drug	CLASS III	Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey	Teva Pharmaceuticals U	Labeling Errors	Nationwide
2 Jun 2021Drug	CLASS II	Estradiol Transdermal System, USP 1 mg/day recalled by Cardinal HealthEstradiol	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
28 Apr 2021Drug	CLASS II	Minivelle (estradiol transdermal system) Delivers recalledMinivelle	Noven Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Estradiol?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.