Quick answers
- What is Estradiol used for?
- The FDA-approved label (Climara, Bayer HealthCare Pharmaceuticals Inc., March 26, 2026) says: “Climara is indicated for: Climara is an estrogen indicated for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Estradiol have a boxed warning?
- Yes. The FDA label for Climara has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Estradiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Estradiol been recalled?
- FDA enforcement reports list 24 recalls of products of this medicine; the newest started September 8, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Estradiol?
- 45 companies list prescription products of Estradiol in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Mylan Pharmaceuticals Inc..
What Estradiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Climara is indicated for: Climara is an estrogen indicated for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. …
— FDA label: Climara, Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026. Read the full label on DailyMed →
The FDA has 130 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
126 of 130 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Patch · Gel · Patch, extended release · Cream · Film, extended release · Insert · Tablet, film coated · Gel, metered · Spray |
|---|---|
| Route | Transdermal · Oral · Topical · Vaginal |
| Prescription products | 255 in the FDA NDC Directory |
| Brand names | Estradiol Vaginal, Dotti, Estradiol Transdermal System, Climara, Divigel, Minivelle, Lyllana, Vivelle-Dot, Estradiol Vaginal Inserts, Estrace, Yuvafem, Estradiol Vaginal Cream |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| estradiol 0.01% cream | Generic | $0.4765 per gram |
| estradiol 0.01% cream | Brand: Estrace | $7.76 per gram |
| estradiol 0.025 mg/d film, extended release | Generic | $8.01 per unit |
| estradiol 0.025 mg/d film, extended release | Brand: Minivelle | $11.59 per unit |
| estradiol 0.025 mg/d patch | Generic | $8.01–$12.33 per patch 4 packages, lowest to highest |
| estradiol 0.025 mg/d patch | Brand: Climara | $18.23 per patch |
| estradiol 0.025 mg/d patch, extended release | Generic | $8.01 per patch |
| estradiol 0.025 mg/d patch, extended release | Brand: Vivelle-Dot | $18.38 per patch |
| estradiol 0.0375 mg/d film, extended release | Generic | $8.26 per unit |
| estradiol 0.0375 mg/d film, extended release | Brand: Minivelle | $11.58 per unit |
| estradiol 0.0375 mg/d patch | Generic | $8.26–$12.78 per patch 4 packages, lowest to highest |
| estradiol 0.0375 mg/d patch | Brand: Climara | $18.30 per patch |
| estradiol 0.0375 mg/d patch, extended release | Generic | $8.26 per patch |
| estradiol 0.0375 mg/d patch, extended release | Brand: Vivelle-Dot | $18.38 per patch |
| estradiol 0.05 mg/d film, extended release | Generic | $8.61 per unit |
| estradiol 0.05 mg/d film, extended release | Brand: Minivelle | $11.58 per unit |
| estradiol 0.05 mg/d patch | Generic | $8.61–$12.22 per patch 4 packages, lowest to highest |
| estradiol 0.05 mg/d patch | Brand: Climara | $18.26 per patch |
| estradiol 0.05 mg/d patch, extended release | Generic | $8.61 per patch |
| estradiol 0.05 mg/d patch, extended release | Brand: Vivelle-Dot | $18.40 per patch |
| estradiol 0.06 mg/d patch | Generic | $12.27 per patch |
| estradiol 0.06 mg/d patch | Brand: Climara | $18.17 per patch |
| estradiol 0.075 mg/d film, extended release | Generic | $8.23 per unit |
| estradiol 0.075 mg/d film, extended release | Brand: Minivelle | $11.57 per unit |
| estradiol 0.075 mg/d patch | Generic | $8.23–$13.32 per patch 4 packages, lowest to highest |
| estradiol 0.075 mg/d patch | Brand: Climara | $18.23 per patch |
| estradiol 0.075 mg/d patch, extended release | Generic | $8.23 per patch |
| estradiol 0.075 mg/d patch, extended release | Brand: Vivelle-Dot | $18.42 per patch |
| estradiol 0.1 mg/d film, extended release | Generic | $8.73 per unit |
| estradiol 0.1 mg/d film, extended release | Brand: Minivelle | $11.57 per unit |
| estradiol 0.1 mg/d patch | Generic | $8.73–$12.77 per patch 4 packages, lowest to highest |
| estradiol 0.1 mg/d patch | Brand: Climara | $18.26 per patch |
| estradiol 0.1 mg/d patch, extended release | Generic | $8.73 per patch |
| estradiol 0.1 mg/d patch, extended release | Brand: Vivelle-Dot | $18.40 per patch |
| estradiol 0.1% gel | Generic | $0.9660 per gram |
| estradiol 0.1% gel | Brand: Divigel | $5.38 per gram |
| estradiol 0.25 mg/0.25 g gel | Generic | $0.8356 per unit |
| estradiol 0.25 mg/0.25 g gel | Brand: Divigel | $5.39 per unit |
| estradiol 0.5 mg tablet | Generic | $0.0620 per tablet |
| estradiol 0.5 mg/0.5 g gel | Generic | $0.8864 per unit |
| estradiol 0.5 mg/0.5 g gel | Brand: Divigel | $5.38 per unit |
| estradiol 0.52 mg/0.87 g gel, metered | Brand: Elestrin | $3.60 per gram |
| estradiol 0.75 mg/0.75 g gel | Generic | $0.6738 per unit |
| estradiol 0.75 mg/0.75 g gel | Brand: Divigel | $5.41 per unit |
| estradiol 0.75 mg/1.25 g gel | Generic | $3.31 per gram |
| estradiol 0.75 mg/1.25 g gel, metered | Generic | $3.31 per gram |
| estradiol 1 mg tablet | Generic | $0.0632 per tablet |
| estradiol 1.25 mg/1.25 g gel | Generic | $0.8425 per gram |
| estradiol 1.25 mg/1.25 g gel | Brand: Divigel | $4.30 per gram |
| estradiol 1.53 mg spray | Brand: Evamist | $18.24 per mL |
| estradiol 10 ug insert | Generic | $5.50 per unit |
| estradiol 10 ug insert | Brand: Vagifem | $20.32 per unit |
| estradiol 10 ug tablet | Generic | $5.50 per tablet |
| estradiol 10 ug tablet, film coated | Generic | $5.50 per tablet |
| estradiol 14 ug/d patch | Brand: Menostar | $38.75 per patch |
| estradiol 2 mg system | Brand: Estring | $551.40 per unit |
| estradiol 2 mg tablet | Generic | $0.0776 per tablet |
| estradiol hemihydrate 0.01% cream | Generic | $0.4765 per gram |
| estradiol hemihydrate 10 ug tablet, film coated | Generic | $5.50 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack25 products
- A-S Medication Solutions21 products
- Mylan Pharmaceuticals Inc.17 products
- Sandoz Inc16 products
- Amneal Pharmaceuticals NY LLC15 products
- Zydus Lifesciences Limited12 products
- Zydus Pharmaceuticals USA Inc.12 products
- Amneal Pharmaceuticals LLC11 products
- Noven Therapeutics, LLC10 products
- NorthStar Rx LLC9 products
- ANI Pharmaceuticals, Inc.9 products
- NuCare Pharmaceuticals, Inc.7 products
- Encube Ethicals, Inc.7 products
- Bayer HealthCare Pharmaceuticals Inc.7 products
- Padagis Israel Pharmaceuticals Ltd6 products
- Asclemed USA, Inc.6 products
- Teva Pharmaceuticals USA, Inc.5 products
- Northwind Health Company, LLC5 products
- Vertical Pharmaceuticals, LLC5 products
- Remedyrepack Inc.5 products
- Trigen Laboratories, LLC5 products
- Xiromed, LLC5 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Epic Pharma, LLC3 products
- Direct_Rx3 products
- PuraCap Laboratories LLC3 products
- Preferred Pharmaceuticals Inc.3 products
- Redpharm Drug3 products
- PharmPak, Inc.2 products
- AvKARE2 products
- Proficient Rx LP2 products
- Prasco Laboratories1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Allergan, Inc.1 product
- Novo Nordisk1 product
- Padagis US LLC1 product
- Pfizer Laboratories Div Pfizer Inc1 product
- American Health Packaging1 product
- Coupler LLC1 product
- Solaris Pharma Corporation1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- ASCEND Therapeutics US, LLC1 product
- Viatris Specialty LLC1 product
- Aurobindo Pharma Limited1 product
- Alvogen Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020375 CLIMARA, MENOSTAR | Bayer Hlthcare | December 22, 1994 | 35, latest February 15, 2024 2024: Labeling · 2024: Labeling · 2021: Labeling |
| NDA020472 ESTRING | Pfizer | April 26, 1996 | 13, latest February 12, 2026 2026: Labeling · 2024: Labeling · 2022: Labeling |
| NDA020538 ESTRADIOL, VIVELLE-DOT | Sandoz | July 31, 1996 | 29, latest February 15, 2024 2024: Labeling · 2021: Labeling · 2021: Labeling |
| NDA020908 VAGIFEM | Novo Nordisk Inc | March 26, 1999 | 21, latest February 15, 2024 2024: Labeling · 2023: Labeling · 2022: Labeling |
| NDA021166 ESTROGEL | Ascend Theraps Us | February 9, 2004 | 12, latest May 19, 2026 2026: Manufacturing (CMC) · 2024: Labeling · 2023: Labeling |
| NDA021813 ELESTRIN | Viatris | December 15, 2006 | 7, latest February 15, 2024 2024: Labeling · 2020: Labeling · 2020: Labeling |
| NDA022014 EVAMIST | Padagis Us | July 27, 2007 | 8, latest February 15, 2024 2024: Labeling · 2023: Labeling · 2017: Labeling |
| NDA022038 DIVIGEL | Vertical Pharms | June 4, 2007 | 9, latest February 12, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| NDA203752 MINIVELLE | Noven | October 29, 2012 | 9, latest February 15, 2024 2024: Labeling · 2021: Labeling · 2021: Labeling |
Generic approvals (28)
- ANDA086069Abbvie · January 31, 1984
- ANDA040197Barr Labs Inc · October 22, 1997
- ANDA040275Epic Pharma LLC · December 29, 1998
- ANDA075182Mylan Technologies · February 24, 2000
- ANDA201675Mylan Technologies · December 19, 2014
- ANDA205256Amneal Pharms · May 29, 2015
- ANDA206388Teva Pharms USA · July 21, 2017
- ANDA208788Mylan · December 29, 2017
- ANDA210194Padagis Israel · January 22, 2018
- ANDA209767Encube · March 5, 2018
- ANDA206685Mylan Technologies · August 15, 2018
- ANDA210264Glenmark Pharms Ltd · September 14, 2018
- ANDA211293Amneal · February 5, 2019
- ANDA211396Amneal · September 28, 2020
- ANDA212313Prasco · July 15, 2021
- ANDA211783Xiromed · August 10, 2022
- ANDA206241Zydus Pharms · December 1, 2022
- ANDA202985Zydus Pharms · March 29, 2023
- ANDA204379Zydus Pharms · April 17, 2023
- ANDA217610Novitium Pharma · August 24, 2023
- ANDA217334Novitium Pharma · September 6, 2023
- ANDA216524Padagis Israel · November 14, 2023
- ANDA216160Solaris Pharma Corp · April 22, 2024
- ANDA216055Amneal · July 12, 2024
- ANDA216550Aurobindo Pharma · August 2, 2024
- ANDA217882Novitium Pharma · October 23, 2024
- ANDA218507Encube · March 5, 2025
- ANDA218214Encube · May 11, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 8, 2026 · Class II · Ongoing · D-0873-2026
Defective Container; packets were found to be either empty or partially full.
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3. — Amneal Pharmaceuticals, LLC
-
May 12, 2026 · Class II · Ongoing · D-0543-2026
Defective Container; packets were found to be either empty or partially full.
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 — ANI Pharmaceuticals, Inc.
-
May 16, 2024 · Class III · Ongoing · D-0543-2024
Failed Impurities/Degradation Specifications.
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- — Zydus Pharmaceuticals (USA) Inc
-
May 16, 2024 · Class III · Ongoing · D-0542-2024
Failed Impurities/Degradation Specifications.
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 — Zydus Pharmaceuticals (USA) Inc
-
February 21, 2023 · Class III · Ongoing · D-0464-2023
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.
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, — Padagis US LLC
-
January 26, 2022 · Class II · Terminated · D-0180-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02 — CARDINAL HEALTHCARE
-
April 16, 2021 · Class II · Terminated · D-0337-2021
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.
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 — Noven Pharmaceuticals Inc
-
April 16, 2021 · Class II · Terminated · D-0336-2021
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.
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 — Noven Pharmaceuticals Inc
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March 15, 2021 · Class II · Terminated · D-0527-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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. — Cardinal Health Inc.
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October 22, 2019 · Class II · Terminated · D-0156-2020
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
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 6846 — Glenmark Pharmaceuticals Inc., USA
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September 26, 2019 · Class II · Terminated · D-0135-2020
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01 — Epic Pharma, LLC
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June 3, 2019 · Class II · Terminated · D-1340-2019
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
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: Glenm — Glenmark Pharmaceuticals Inc., USA
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December 26, 2018 · Class II · Terminated · D-0350-2019
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
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
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December 4, 2018 · Class II · Terminated · D-0297-2019
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01 — Epic Pharma, LLC
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September 7, 2018 · Class II · Terminated · D-1207-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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, Florid — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1210-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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 6 — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1208-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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 3 — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1209-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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 6 — Noven Pharmaceuticals, Inc.
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May 4, 2018 · Class II · Terminated · D-0862-2018
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.
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 Pharmaceuticals, Inc.
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May 4, 2018 · Class II · Terminated · D-0863-2018
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.
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. — Noven Pharmaceuticals, Inc.
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March 19, 2018 · Class II · Terminated · D-0620-2018
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
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 Wale — Teva Pharmaceuticals USA
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February 26, 2018 · Class II · Terminated · D-0608-2018
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.
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 — Paddock Laboratories, LLC.
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April 27, 2017 · Class III · Terminated · D-0923-2017
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
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 — Noven Pharmaceuticals, Inc.
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February 25, 2015 · Class II · Terminated · D-0485-2015
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
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 68968-66 — Noven Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197657, 197658, 197659, 226597, 238003, 238004, 241527, 241946, 242333, 242891 … (+10) |
|---|---|
| SPL set ID of the quoted label | 1e9702c4-f2d7-4ea8-b6e8-7dca31671864 |
| FDA labels (SPL) | 130 |
| FDA applications | NDA020375, NDA020472, NDA020538, NDA020908, NDA021166, NDA021813, NDA022014, NDA022038, NDA203752, 28 ANDA |
| Active ingredients (FDA) | ESTRADIOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Climara, Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →