Estrogen, Progestin
Where is Ethinyl Estradiol and Norethindrone made?
16 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 11 factories in India, the United States, Spain, China and Canada.
India 4United States 3Spain 2China 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals0.4 mg / 0.035 mg, 1 mg / 20 ug · NDC 65162-347, 69238-1581, 65162-316 +3 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Watson Laboratories, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record | |
| Glenmark Pharmaceuticals Inc., USA0.4 mg / 0.035 mg, 0.5 mg / 2.5 ug, 1 mg / 0.02 mg, 1 mg / 0.035 mg, 1 mg / 20 ug, 1 mg / 5 ug · NDC 68462-316, 68462-656, 68462-419 +8 | Cyndea Pharma SLMakes it and tests it | Soria, Spain | Problems found, fixed voluntarilyMar 2022 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 | |
| Lupin Pharmaceuticals, Inc.0.4 mg / 0.035 mg, 0.5 mg / 0.0025 mg, 0.8 mg / 0.025 mg, 1 mg / 0.005 mg, 1 mg / 0.02 mg, 1 mg / 0.035 mg · NDC 68180-898, 68180-899, 68180-875 +11 | Lupin LimitedMakes it, makes the active ingredient and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Warner Chilcott Company, LLCMakes it, tests it and packages it | Manati, Puerto Rico, United States | Problems found, fixed voluntarilyOct 2016 | |
| Xiromed, LLC.0.4 mg / 0.035 mg, 0.8 mg / 0.025 mg, 1 mg / 0.02 mg, 1 mg / 20 ug, 1.5 mg / 0.03 mg, 6 ingredients · NDC 70700-308, 70700-306, 70700-152 +6 | Laboratorios Leon Farma SAUMakes it, tests it, packages it and labels it | Villaquilambre, Spain | Problems found, fixed voluntarilyJul 2025 |
| Patheon Softgels Inc.Makes it and tests it | High Point, NC, United States | Problems found, fixed voluntarilyJul 2025 | |
| Afaxys Pharma LLC1 mg / 20 ug · NDC 50102-228 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Apotex Corp.1 mg / 0.35 mg · NDC 60505-4901 | Naari Pharma Private LimitedMakes it | Rudrapur, India | Not inspected on record |
| Aurobindo Pharma Limited0.4 mg / 0.035 mg, 0.5 mg / 0.035 mg, 1 mg / 0.02 mg, 1 mg / 0.035 mg, 1 mg / 20 ug, 6 ingredients · NDC 65862-926, 59651-740, 65862-899 +7 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Dr. Reddy's Laboratories Inc.0.5 mg / 0.035 mg, 1 mg / 0.02 mg, 1 mg / 20 ug, 1.5 mg / 0.03 mg, 6 ingredients, 30 ug / 1.5 mg · NDC 75907-085, 75907-084, 75907-082 +3 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Mayne Pharma Inc.0.5 mg / 0.035 mg, 1 mg / 0.02 mg, 1.5 mg / 0.03 mg, 6 ingredients · NDC 51862-892, 51862-868, 51862-648 +4 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Millicent US, Inc. Femlyv1 mg / 20 ug · NDC 72495-601 | Patheon Inc.Makes it, tests it and labels it | Mississauga, Canada | Problems found, fixed voluntarilyFeb 2023 |
| Naari Pte. Limited0.4 mg / 0.03 mg, 1 mg / 0.35 mg · NDC 79929-005, 79929-007 | Naari Pharma Private LimitedMakes it, tests it and packages it | Rudrapur, India | Not inspected on record |
| Northstar Rx LLC.0.4 mg / 0.035 mg, 0.5 mg / 0.035 mg, 1 mg / 0.02 mg, 1 mg / 0.035 mg, 1 mg / 20 ug, 1.5 mg / 0.03 mg · NDC 16714-347, 16714-370, 16714-408 +6 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Allergan, Inc. Lo Loestrin Fe, Taytulla1 mg / 0.01 mg, 1 mg / 0.02 mg · NDC 0430-0420, 0023-5862 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.4 mg / 0.035 mg, 1 mg / 0.02 mg, 1.5 mg / 0.03 mg, 6 ingredients · NDC 0378-7297, 0378-7280, 0378-7283 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.4 mg / 0.035 mg, 0.5 mg / 0.035 mg, 1 mg / 0.02 mg, 1 mg / 0.035 mg, 1 mg / 20 ug, 1 mg / 5 ug · NDC 0555-9034, 0555-9008, 0093-5328 +11 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Women's Health LLC1 mg / 20 ug, 30 ug / 1.5 mg · NDC 51285-131, 51285-125, 51285-127 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ethinyl Estradiol and Norethindrone 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:
50090-3229,50090-6321,50090-1456,50090-2478+4 - Bryant Ranch Prepack:
63629-5628 - Central Texas Community Health Centers:
76413-105,76413-104,76413-150 - Direct Rx:
72189-215 - Dispensing Solutions Inc.:
68258-5005 - PD-Rx Pharmaceuticals, Inc.:
72789-450 - Physicians Total Care, Inc.:
54868-6161,54868-6273,54868-4045,54868-6100+8 - Preferred Pharmaceuticals, Inc..:
68788-6832,68788-8113 - Proficient Rx LP:
71205-547,82804-172,82804-096,63187-890+1 - RPK Pharmaceuticals, Inc.:
53002-1725,53002-1734,53002-2616,53002-3711+3 - Rebel Distributors Corp..:
42254-287,21695-857,42254-242,21695-685 - RedPharm Drug. Inc.:
67296-1159
Recalls
- May 27, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. - Jan 25, 2024 · Class III · Teva Pharmaceuticals USA, Inc · 2 recall notices
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jul 21, 2020 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. - Dec 26, 2019 · Class II · Lupin Pharmaceuticals Inc.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack. - Jul 2, 2019 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study. - May 24, 2018 · Class I · Allergan, PLC.
Contraceptive Tablets Out of Sequence. - May 16, 2017 · Class I · Lupin Limited (Unit 1)
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package. - Jan 30, 2017 · Class III · Mylan Pharmaceuticals Inc.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. - Mar 15, 2013 · Class III · Teva Pharmaceuticals USA, Inc. · 2 recall notices
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.