Corticosteroid
Where is Budesonide made?
25 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 18 factories in the United States, India, Italy, France, China and Switzerland.
United States 7India 6Italy 2France 1China 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals0.25 mg per 2 mL, 0.5 mg per 2 mL, 3 mg · NDC 0115-1687, 0115-1689, 65162-778 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Woodstock Sterile Solutions, Inc.Makes it, tests it, packages it and labels it | Woodstock, IL, United States | No problems foundOct 2022 | |
| Calliditas Therapeutics AB Tarpeyo4 mg · NDC 81749-004 | Minakem Dunkerque ProductionMakes the active ingredient | Dunkerque, France | Problems found, fixed voluntarilyMay 2021 |
| Patheon Pharmaceuticals Inc.Makes it | Cincinnati, OH, United States | Problems found, fixed voluntarilySep 2025 | |
| Sicor Societa' Italiana Corticosteroidi s.r.l ABBREVIATA IN SICOR S.R.L.Makes the active ingredient | Santhia, Italy | Problems found, fixed voluntarilyApr 2022 | |
| Cipla USA., Inc.0.25 mg per 2 mL, 0.5 mg per 2 mL, 1 mg per 2 mL · NDC 69097-318, 69097-319, 69097-321 | Cipla (Jiangsu) Pharmaceutical Co., Ltd.Makes it | Qidong, China | Not inspected on record |
| Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 | |
| Cipla LimitedMakes it | Indore, India | Serious problems, FDA actionFeb 2023 | |
| Oceanside Pharmaceuticals.2 mg, 9 mg · NDC 68682-658, 68682-309 | Asm Aerosol-Service AgMakes it | Möhlin, Switzerland | Problems found, fixed voluntarilyNov 2023 |
| Cosmo SpAMakes it | Lainate, Italy | Problems found, fixed voluntarilyNov 2022 | |
| DPT Laboratories, Ltd.Makes it | San Antonio, TX, United States | No problems foundMay 2025 | |
| Exelan Pharmaceuticals, Inc.0.25 mg per 2 mL, 0.5 mg per 2 mL, 1 mg per 2 mL · NDC 76282-640, 76282-641, 76282-642 | Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Cipla LimitedMakes it | Indore, India | Serious problems, FDA actionFeb 2023 | |
| Salix Pharmaceuticals, Inc. Uceris2 mg · NDC 65649-651 | Asm Aerosol-Service AgMakes it | Möhlin, Switzerland | Problems found, fixed voluntarilyNov 2023 |
| DPT Laboratories, Ltd.Makes it | San Antonio, TX, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Aurobindo Pharma Limited0.5 mg per 2 mL · NDC 59651-585 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Cadila Healthcare Limited3 mg · NDC 70771-1075 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.0.25 mg per 2 mL, 0.5 mg per 2 mL, 1 mg per 2 mL · NDC 47335-631, 47335-632, 47335-633 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Chartwell RX, LLC.0.25 mg per 2 mL, 0.5 mg per 2 mL · NDC 62135-822, 62135-823 | Nephron SC, LLCMakes it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Lupin Pharmaceuticals, Inc.0.5 mg per 2 mL · NDC 68180-984 | The Ritedose CorporationMakes it and packages it | Columbia, SC, United States | Problems found, fixed voluntarilyFeb 2025 |
| Nephron Pharmaceuticals Corporation0.25 mg per 2 mL, 0.5 mg per 2 mL · NDC 0487-9601, 0487-9701 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Northstar Rx LLC.3 mg · NDC 16714-829 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Rising Pharma Holdings, Inc.0.25 mg per 2 mL, 0.5 mg per 2 mL · NDC 64980-638, 64980-639 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Santarus, Inc.. Uceris9 mg · NDC 68012-309 | Cosmo SpAMakes it | Lainate, Italy | Problems found, fixed voluntarilyNov 2022 |
| Zydus Pharmaceuticals (USA) Inc.3 mg · NDC 68382-720 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Actavis Pharma, Inc.9 mg · NDC 0591-2510 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AstraZeneca Pharmaceuticals LP Pulmicort Respules, Pulmicortflexhaler0.25 mg per 2 mL, 0.5 mg per 2 mL, 1 mg per 2 mL, 90 ug, 180 ug · NDC 0186-1988, 0186-1989, 0186-1990 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| H2-Pharma LLC Pulmicortflexhaler90 ug, 180 ug · NDC 61269-518, 61269-509 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.9 mg · NDC 0378-4500 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd2 mg · NDC 45802-627 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC3 mg · NDC 0574-9855 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Rubicon Holdings Inc. Pulmicort Flexhaler90 ug, 180 ug · NDC 85612-011, 85612-010 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Takeda Pharmaceuticals America, Inc. Eohilia2 mg per 10 mL · NDC 64764-105 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.25 mg per 2 mL, 0.5 mg per 2 mL, 1 mg per 2 mL · NDC 0093-6815, 0093-6816, 0093-6817 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Budesonide 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:
50090-1467,50090-7173,50090-6590,50090-6586+4 - American Health Packaging:
60687-889,60687-524,60687-596 - Bryant Ranch Prepack:
63629-8294,72162-2473 - Cardinal Health 107, LLC:
55154-4849 - Carilion Materials Management:
68151-4374 - Dispensing Solutions Inc.:
68258-8922 - Golden State Medical Supply, Inc.:
51407-591 - Major Pharmaceuticals:
0904-7313 - Physicians Total Care, Inc.:
54868-3423,54868-5774,54868-3550,54868-5621+3 - Preferred Pharmaceuticals, Inc..:
68788-8429,68788-7314,68788-8503 - Rebel Distributors Corp..:
21695-291 - Remedyrepack Inc.:
70518-4613 - Ritedose Pharmaceuticals, LLC:
76204-018
Recalls
- May 29, 2026 · Class II · Sun Pharmaceutical Industries Inc
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution - Jun 30, 2025 · Class II · Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. - Jan 8, 2024 · Class II · Teva Pharmaceuticals USA, Inc
Failed Dissolution Specifications - Sep 15, 2022 · Class II · Cipla
Lack of Assurance of Sterility - Jan 11, 2013 · Class III · AstraZeneca LP · 2 recall notices
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.