Estrogen, Progestin
Where is Ethinyl Estradiol and Levonorgestrel made?
19 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 12 factories in India, Spain, the Netherlands, China, the United States, Canada and 1 other.
India 4Spain 2Netherlands 2China 1United States 1Canada 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Xiromed, LLC.0.01 mg / 0.03 mg / 0.15 mg, 0.03 mg / 0.15 mg, 0.1 mg / 0.01 mg / 0.02 mg, 0.1 mg / 0.02 mg, 7 ingredients · NDC 70700-206, 70700-123, 70700-117 +7 | Aspen Oss B.V.Makes the active ingredient | Oss, Netherlands | Problems found, fixed voluntarilyNov 2022 |
| Aspen Oss B.V.Makes the active ingredient | Oss, Netherlands | Problems found, fixed voluntarilyNov 2022 | |
| Laboratorios Leon Farma SAUMakes it, tests it, packages it and labels it | Villaquilambre, Spain | Problems found, fixed voluntarilyJul 2025 | |
| Everett Laboratories, Inc. Tyblume, Twirla0.1 mg / 0.02 mg, 2.3 mg / 2.6 mg · NDC 0642-7471, 71671-100 | Corium Innovations, Inc.Makes it and packages it | Grand Rapids, MI, United States | Problems found, fixed voluntarilyNov 2022 |
| Laboratorios Leon Farma SAUMakes it, tests it, packages it and labels it | Villaquilambre, Spain | Problems found, fixed voluntarilyJul 2025 | |
| Ohm Laboratories Inc.0.1 mg / 0.02 mg · NDC 51660-572 | Bayer Pharma AGMakes the active ingredient | Location not on file | Not inspected on record |
| Haupt Pharma Muenster GmbHMakes it | Muenster, Germany | Problems found, fixed voluntarilyNov 2024 | |
| Acella Pharmaceuticals, LLC levonorgestrel and ethinyl estradiol0.1 mg / 0.02 mg · NDC 42192-623 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Afaxys Pharma LLC0.03 mg / 0.15 mg, 0.1 mg / 0.02 mg · NDC 50102-230, 50102-220 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Apotex Corp.0.03 mg / 0.15 mg, 0.1 mg / 0.02 mg · NDC 60505-4899, 60505-4898 | Naari Pharma Private LimitedMakes it | Rudrapur, India | Not inspected on record |
| Aurobindo Pharma Limited0.01 mg / 0.03 mg / 0.15 mg, 0.03 mg / 0.15 mg, 0.1 mg / 0.01 mg / 0.02 mg, 0.1 mg / 0.02 mg · NDC 65862-864, 65862-865, 65862-848 +2 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Avion Pharmaceuticals, LLC Balcoltra0.1 mg / 0.02 mg · NDC 75854-602 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Camber Pharmaceuticals Inc.0.1 mg / 0.02 mg · NDC 31722-944 | Cyndea Pharma SLMakes it | Soria, Spain | Problems found, fixed voluntarilyMar 2022 |
| Dr. Reddy's Laboratories Inc.0.1 mg / 0.02 mg · NDC 55741-005 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Glenmark Pharmaceuticals Inc., USA0.01 mg / 0.03 mg / 0.15 mg, 0.03 mg / 0.15 mg, 20 ug / 90 ug · NDC 68462-646, 68462-388, 68462-672 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Ingenus Pharmaceuticals, LLC20 ug / 90 ug · NDC 50742-659 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Lupin Pharmaceuticals, Inc.0.01 mg / 0.03 mg / 0.15 mg, 0.03 mg / 0.15 mg, 0.1 mg / 0.01 mg / 0.02 mg, 0.1 mg / 0.02 mg, 6 ingredients, 30 ug / 0.15 mg · NDC 68180-846, 68180-843, 68180-848 +4 | Lupin LimitedMakes it, makes the active ingredient and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Mayne Pharma Inc.0.03 mg / 0.15 mg, 0.1 mg / 0.02 mg · NDC 51862-097, 51862-545, 51862-028 | Patheon Inc.Makes it, tests it, packages it and labels it | Mississauga, Canada | Problems found, fixed voluntarilyFeb 2023 |
| Naari Pte. Limited0.03 mg / 0.15 mg, 0.1 mg / 0.02 mg · NDC 79929-003, 79929-004 | Naari Pharma Private LimitedMakes it, tests it, packages it and labels it | Rudrapur, India | Not inspected on record |
| Northstar Rx LLC.0.03 mg / 0.15 mg, 0.1 mg / 0.02 mg, 6 ingredients · NDC 16714-366, 16714-359, 16714-340 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Mylan Pharmaceuticals Inc.0.1 mg / 0.01 mg / 0.02 mg, 0.1 mg / 0.02 mg, 7 ingredients · NDC 0378-7284, 0378-7287, 0378-7316 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.01 mg / 0.03 mg / 0.15 mg, 0.03 mg / 0.15 mg, 0.1 mg / 0.01 mg / 0.02 mg, 0.1 mg / 0.02 mg, 7 ingredients · NDC 0093-3134, 0555-9020, 0555-9123 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.20 ug / 90 ug · NDC 0480-3472 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ethinyl Estradiol and Levonorgestrel 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:
50090-2505,50090-6374,50090-2097,50090-1380+2 - Bryant Ranch Prepack:
63629-2345,63629-2343,63629-2344,63629-5651 - Central Texas Community Health Centers:
76413-111,76413-116 - Physicians Total Care, Inc.:
54868-6276,54868-6044,54868-4607,54868-6275+4 - Proficient Rx LP:
63187-889 - RPK Pharmaceuticals, Inc.:
53002-1565,53002-2683,53002-1779,53002-1632+4 - Rebel Distributors Corp..:
42254-260,21695-995,21695-855 - RedPharm Drug. Inc.:
67296-1652
Recalls
- Mar 9, 2020 · Class II · Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. - Sep 18, 2018 · Class III · Xiromed LLC
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion. - 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 - Mar 14, 2013 · Class III · Teva Pharmaceuticals USA, Inc.
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing - Mar 12, 2013 · Class III · Teva Pharmaceuticals USA, Inc. · 2 recall notices
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. - Apr 23, 2012 · Class III · Teva Pharmaceuticals USA, Inc.
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.