Estrogen
Where is Estradiol made?
38 companies sell it under their own name and 23 repackagers rebottle it. Their labels name 22 factories in the United States, India, Spain, the United Kingdom and Denmark.
United States 14India 4Spain 2United Kingdom 1Denmark 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d, 0.25 mg per 0.25 g · NDC 69238-1629, 65162-126, 65162-989 +24 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 | |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 | |
| Xiromed, LLC.0.25 mg per 0.25 g, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 1 mg per 1 g, 1.25 mg per 1.25 g, 10 mg per 1 mL · NDC 70700-143, 70700-144, 70700-194 +5 | Laboratorios Farmalan, S.A.Makes it, tests it and sterilizes it | Villaquilambre, Spain | Problems found, fixed voluntarilyOct 2024 |
| Laboratorios Leon Farma SAUMakes it, tests it, packages it and labels it | Villaquilambre, Spain | Problems found, fixed voluntarilyJul 2025 | |
| ANI Pharmaceuticals, Inc.0.25 mg per 0.25 g, 0.5 mg, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 0.75 mg per 1.25 g, 1 mg · NDC 70954-531, 70954-564, 70954-530 +6 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| ASCEND Therapeutics U.S., LLC EstroGel0.75 mg per 1.25 g · NDC 17139-617 | DPT Laboratories, Ltd.Makes it | San Antonio, TX, United States | No problems foundMay 2024 |
| Advanced Pharmaceutical Technology, Inc.25 mg, 50 mg · NDC 57377-025, 57377-050 | Advanced Pharmaceutical Technology, Inc.Makes it | Elmsford, NY, United States | Serious problems, FDA actionAug 2024 |
| American Regent, Inc.20 mg per 1 mL, 40 mg per 1 mL · NDC 0517-0420, 0517-0440 | American Regent, Inc.Makes it | New Albany, OH, United States | Problems found, fixed voluntarilyJan 2026 |
| Aurobindo Pharma Limited10 ug · NDC 59651-439 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Bayer HealthCare Pharmaceuticals Inc. Climara, Menostar0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d · NDC 50419-454, 50419-456, 50419-451 +4 | Kindeva Drug Delivery L.P.Makes it | Northridge, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Cadila Healthcare Limited0.014 mg per 1 d, 0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d · NDC 70771-1400, 70771-1563, 70771-1401 +9 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Encube Ethicals, Inc.0.1 mg per 1 g, 0.25 mg per 0.25 g, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 0.75 mg per 1.25 g, 1 mg per 1 g · NDC 21922-085, 21922-086, 21922-087 +4 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Epic Pharma, LLC0.5 mg, 1 mg, 2 mg · NDC 42806-087, 42806-088, 42806-089 | Granulation Technology, Inc.Makes it | Fairfield, NJ, United States | Not inspected on record |
| Glenmark Pharmaceuticals Inc., USA10 ug · NDC 68462-711 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Mayne Pharma Inc. Imvexxy4 ug, 10 ug · NDC 68308-748, 68308-747 | Catalent Pharma Solutions, LLCMakes it and tests it | St Petersburg, FL, United States | Problems found, fixed voluntarilyJan 2026 |
| Mayne Pharma LLC Imvexxy4 ug, 10 ug · NDC 50261-110, 50261-104 | Catalent Pharma SolutionsMakes it and tests it | Allendale, New Jersey, United States | No problems foundOct 2011 |
| Millicent US, Inc. Femring0.05 mg per 1 d, 0.1 mg per 1 d · NDC 72495-201, 72495-301, 72495-202 +1 | Millicent Pharma (NI) LimitedMakes it | Larne, United Kingdom | Problems found, fixed voluntarilyMar 2026 |
| Northstar Rx LLC.0.25 mg per 0.25 g, 0.5 mg, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 1 mg, 1 mg per 1 g · NDC 72603-241, 72603-273, 72603-242 +6 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Noven Therapeutics, LLC Minivelle0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.050 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d · NDC 68968-3425, 68968-6625, 68968-3437 +7 | Noven Pharmaceuticals, Inc.Makes it | Miami, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Novo Nordisk Vagifem10 ug · NDC 0169-5176 | Novo Nordisk A/S - G8, X9 M.Fl.Makes it | Malov, Denmark | Problems found, fixed voluntarilyApr 2026 |
| Pharmacia & Upjohn Company LLC5 mg per 1 mL · NDC 0009-0271 | Pharmacia & Upjohn Company LLCMakes it, makes the active ingredient, tests it, packages it and labels it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Praxis, LLC0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d · NDC 59368-421, 59368-423, 59368-420 +3 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals0.5 mg, 1 mg, 2 mg · NDC 24658-702, 24658-703, 24658-704 | Granulation Technology, Inc.Makes it | Fairfield, NJ, United States | Not inspected on record |
| Zydus Pharmaceuticals (USA) Inc.0.014 mg per 1 d, 0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d · NDC 68382-323, 70710-1191, 68382-324 +9 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Allergan, Inc.0.1 mg per 1 g · NDC 0430-3754 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Alvogen Inc.0.1 mg per 1 g · NDC 47781-104 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.0.1 mg per 1 g, 10 ug · NDC 42291-426, 42291-962 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc. Delestrogen10 mg per 1 mL, 20 mg per 1 mL · NDC 42023-110, 42023-111 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.10 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 0143-9289, 0143-9290, 0143-9291 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d · NDC 0378-4644, 0378-3349, 0378-4619 +14 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd0.1 mg per 1 g, 0.25 mg per 0.25 g, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 1 mg per 1 g, 1.25 mg per 1.25 g · NDC 45802-097, 45802-134, 45802-202 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC Evamist1.53 mg · NDC 0574-2067 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Estring2 mg · NDC 0013-1042 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories0.1 mg per 1 g · NDC 66993-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Vivelle-Dot0.025 mg per 1 d, 0.0375 mg per 1 d, 0.05 mg per 1 d, 0.06 mg per 1 d, 0.075 mg per 1 d, 0.1 mg per 1 d · NDC 0781-7119, 0781-7129, 66758-145 +13 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solaris Pharma Corporation0.75 mg per 1.25 g · NDC 73473-308 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.1 mg per 1 g, 0.5 mg, 1 mg, 2 mg, 10 ug · NDC 0093-3541, 0555-0899, 0555-0886 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trigen Laboratories, LLC0.25 mg per 0.25 g, 0.5 mg per 0.5 g, 0.75 mg per 0.75 g, 1 mg per 1 g, 1.25 mg per 1.25 g · NDC 13811-090, 13811-091, 13811-092 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Vertical Pharmaceuticals, LLC Divigel.25 mg per .25 g, .5 mg per .5 g, .75 mg per .75 g, 1 mg per 1 g, 1.25 mg per 1.25 g · NDC 68025-065, 68025-066, 68025-083 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Elestrin0.52 mg per 0.87 g · NDC 0037-4801 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Estradiol in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-7985,50090-7610,50090-7987,50090-7611+19 - Aidarex Pharmaceuticals LLC:
33261-667,33261-714 - American Health Packaging:
60687-876 - Asclemed USA, Inc.:
76420-021,76420-022,76420-023 - Atlantic Biologicals Corps.:
17856-0089 - Blenheim Pharmacal, Inc.:
10544-069,10544-070 - Bryant Ranch Prepack:
72162-2032,72162-2033,72162-2034,72162-2035+23 - Coupler LLC:
67046-1568 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-798,70934-506,70934-215,70934-541+3 - Direct Rx:
61919-198,72189-655,61919-278,61919-195+4 - Northwind Pharmaceuticals:
51655-860,82868-038,51655-229,82868-026+1 - NuCare Pharmaceuticals.Inc.:
68071-3796,68071-2694,68071-3629,68071-3394+4 - PD-Rx Pharmaceuticals, Inc.:
72789-489,72789-299,72789-360 - PharmPak, Inc.:
54348-701,54348-702 - Physicians Total Care, Inc.:
54868-4862,54868-4920,54868-4242,54868-4243+12 - Preferred Pharmaceuticals, Inc..:
68788-8626,68788-7054,68788-8860,68788-7102 - Proficient Rx LP:
63187-741,82804-319 - RPK Pharmaceuticals, Inc.:
53002-1807,53002-1808,53002-1434 - ReadyMeds:
64205-048,64205-488 - Rebel Distributors Corp..:
21695-613,21695-623 - RedPharm Drug. Inc.:
67296-2258,67296-2303,67296-2279 - Remedyrepack Inc.:
70518-0834,70518-3922,70518-3818,70518-2369+2 - Stat Rx USA:
16590-052,16590-278
Recalls
- Sep 8, 2026 · Class II · Amneal Pharmaceuticals, LLC
Defective Container; packets were found to be either empty or partially full. - May 12, 2026 · Class II · ANI Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full. - May 16, 2024 · Class III · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Impurities/Degradation Specifications. - Feb 21, 2023 · Class III · Padagis US LLC
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. - Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Apr 16, 2021 · Class II · Noven Pharmaceuticals Inc · 2 recall notices
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. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Oct 22, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. - Sep 26, 2019 · Class II · Epic Pharma, LLC
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets. - Jun 3, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. - Dec 26, 2018 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator - Dec 4, 2018 · Class II · Epic Pharma, LLC
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.