Estradiol recalls: 23 FDA reports
Recalls involving Estradiol. What was wrong with each batch, and how the FDA graded the risk.
23Reports
0Class I
4Ongoing
2026-05-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceu
D-0543-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Defective Container; packets were found to be either empty or partially full.
- Product
- Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Where it went
- Nationwide in the USA
- How much
- 3964 Cartons
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limi
D-0543-2024 · Class III · reported 2024-06-12 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications.
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
- Where it went
- Nationwide within the United States
- How much
- 13,440 units
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Lim
D-0542-2024 · Class III · reported 2024-06-12 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications.
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
- Where it went
- Nationwide within the United States
- How much
- 21,360 units
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC
D-0180-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
- Where it went
- Nationwide USA
- How much
- 1 unit
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pu
D-0464-2023 · Class III · reported 2023-03-22 · Ongoing
- Why it was recalled
- 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.
- Product
- Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
- Where it went
- Nationwide in the USA
- How much
- 43,238 cartons
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manuf
D-0527-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Where it went
- FL, GA, SC
- How much
- 72 cartons
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, I
D-0337-2021 · Class II · reported 2021-04-28 · Terminated
- Why it was recalled
- 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.
- Product
- Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
- Where it went
- Nationwide within the United States
- How much
- 10872 cartons
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmac
D-0336-2021 · Class II · reported 2021-04-28 · Terminated
- Why it was recalled
- 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.
- Product
- Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
- Where it went
- Nationwide within the United States
- How much
- 12060 cartons
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) pe
D-0156-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
- Product
- Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
- Where it went
- Nationwide in the USA
- How much
- 216,840 cartons
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, N
D-0135-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
- Product
- Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
- Where it went
- Nationwide within the United States
- How much
- 11,472 (bottles of 100)
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx
D-1340-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
- Product
- Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
- Where it went
- U.S.A. Nationwide
- How much
- 31,656 boxes
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (ND
D-0350-2019 · Class II · reported 2019-01-16 · Terminated
- Why it was recalled
- Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
- Product
- Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
- Where it went
- Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
- How much
- 96,240 applicators
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413,
D-0297-2019 · Class II · reported 2018-12-26 · Terminated
- Why it was recalled
- Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
- Product
- Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
- Where it went
- U.S.A. Nationwide
- How much
- 2976 bottles
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Nove
D-1209-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Product
- Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
- Where it went
- Nationwide
- How much
- 26217 boxes of 8 patches
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only
D-1207-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Product
- Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
- Where it went
- Nationwide
- How much
- 213714 boxes of 8 patches and 15927 boxes of 2 patches
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Nove
D-1210-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Product
- Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
- Where it went
- Nationwide
- How much
- 74908 boxes of 8 patches
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only,
D-1208-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Product
- Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
- Where it went
- Nationwide
- How much
- 149631 boxes of 8 patches and 15809 boxes of 2 patches
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouc
D-0862-2018 · Class II · reported 2018-05-16 · Terminated
- Why it was recalled
- 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.
- Product
- Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
- Where it went
- Nationwide in the USA.
- How much
- 61960 boxes
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 p
D-0863-2018 · Class II · reported 2018-05-16 · Terminated
- Why it was recalled
- 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.
- Product
- Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
- Where it went
- Nationwide in the USA.
- How much
- 70870 boxes
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufa
D-0608-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- 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.
- Product
- Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
- Where it went
- Nationwide within the USA.
- How much
- 52,596 bottles
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/ca
D-0620-2018 · Class II · reported 2018-03-28 · Terminated
- Why it was recalled
- Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
- Product
- Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.
- Where it went
- Distributed within the United States and Puerto Rico.
- How much
- 640,486 vaginal inserts
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Nove
D-0923-2017 · Class III · reported 2017-07-05 · Terminated
- Why it was recalled
- Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
- Product
- Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
- Where it went
- Nationwide within US
- How much
- 14434 cartons
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceutic
D-0485-2015 · Class II · reported 2015-04-22 · Terminated
- Why it was recalled
- Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- Product
- Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
- Where it went
- Nationwide
- How much
- 720 transdermal patches
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls