Estradiol recalls

The FDA has published 71 recalls involving Estradiol since 2013. The latest was reported on 27 May 2026. Most were for sterility. The Compounding Pharmacy of America 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 recalls71since 2013

Last 12 months10reported

Class I00% of total

Ongoing15latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 1 0 0May 0 0 0Aug 0 0 0Nov 0 0 9Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 65 92%Class III 6 8%

Why estradiol is recalled

Companies

The Compounding Pharmacy of America1217%
Noven Pharmaceuticals1217%
JD & SN Inc1115%
F.H. Investments Inc. (913%
Glenmark Pharmaceuticals Inc., USA34%
Teva Pharmaceuticals USA34%
South Coast Specialty Compounding34%
Epic Pharma23%

Brands

Minivelle913%
Estradiol710%
Estradiol Vaginal Inserts34%
Mimvey23%
Combipatch (estradiol/norethindrone Acetate Transdermal System)23%
Evamist23%

By year

20261014%
202511%
202434%
202311%
202223%
202157%
202023%
201946%
2018913%
201734%

Ongoing estradiol recalls

15 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
18 Feb 2026Drug	CLASS II	Estradiol, 6 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 12.5 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide

All estradiol recalls, newest first

71 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
18 Feb 2026Drug	CLASS II	Estradiol, 6 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 12.5 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 37.5 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 20 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 10 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Estradiol, 25 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. (	F.H. Investments Inc. (	Particulate Matter	Nationwide
5 Mar 2025Drug	CLASS II	Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets recalled by Padagis US	Padagis US	Packaging Defects	Nationwide
12 Jun 2024Drug	CLASS III	Estradiol Transdermal System, USP (Twice-Weekly) 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
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 USA	Labeling Errors	Nationwide
9 Feb 2022Drug	CLASS III	Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey	Teva Pharmaceuticals USA	Labeling Errors	Nationwide
25 Aug 2021Drug	CLASS II	Combipatch (estradiol/norethindrone acetate transdermal recalledCombipatch (estradiol/norethindrone Acetate Transdermal System)	Noven Pharmaceuticals	Potency & Assay	Nationwide
25 Aug 2021Drug	CLASS II	Combipatch (estradiol/norethindrone acetate transdermal recalledCombipatch (estradiol/norethindrone Acetate Transdermal System)	Noven Pharmaceuticals	Potency & Assay	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	Minivelle (estradiol transdermal system) Delivers recalledMinivelle	Noven Pharmaceuticals	Potency & Assay	Nationwide
28 Apr 2021Drug	CLASS II	Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box recalledEstradiol	Noven Pharmaceuticals	Potency & Assay	Nationwide
22 Apr 2020Drug	CLASS II	Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL recalled	The Medicine Shoppe Pharmacy	Other	FL
22 Apr 2020Drug	CLASS II	Estradiol, USP (Non-Micronized) (Hemihydrate) recalled	B & B Pharmaceuticals	Foreign Material	Nationwide
6 Nov 2019Drug	CLASS II	Estradiol Vaginal Inserts USP, 10 mcg recalledEstradiol Vaginal Inserts	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
16 Oct 2019Drug	CLASS II	Estradiol tablets, 0.5 mg recalled by Epic Pharma	Epic Pharma	Other	Nationwide
19 Jun 2019Drug	CLASS II	Estradiol Vaginal Inserts USP 10 mcg recalledEstradiol Vaginal Inserts	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
16 Jan 2019Drug	CLASS II	Estradiol Vaginal Inserts, USP, 10 mcg recalledEstradiol Vaginal Inserts	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
26 Dec 2018Drug	CLASS II	Estradiol Tablets, USP, 2 mg recalled by Epic Pharma	Epic Pharma	Other	Nationwide
3 Oct 2018Drug	CLASS II	Minivelle (estradiol transdermal system) Patches 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.