beta2-Adrenergic Agonist
Where is Levalbuterol made?
11 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 5 factories in India, the United States and China.
India 3United States 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 0.5 mL, 1.25 mg per 3 mL · NDC 65862-943, 65862-944, 65862-942 +1 | Aarti Pharmalabs LimitedMakes the active ingredient | Tarapur, India | Problems found, fixed voluntarilyMar 2026 |
| Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 | |
| Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.Makes it and tests it | Chengdu, China | Not inspected on record | |
| Amneal Pharmaceuticals0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 0115-9930, 0115-9931, 0115-9932 | The Ritedose CorporationMakes it, packages it and labels it | Columbia, SC, United States | Problems found, fixed voluntarilyFeb 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 47335-743, 47335-746, 47335-753 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 81894-101, 81894-102, 81894-103 | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.Makes it and tests it | Chengdu, China | Not inspected on record |
| Ritedose Pharmaceuticals, LLC0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 76204-700, 76204-002, 76204-800 +2 | The Ritedose CorporationMakes it, packages it and labels it | Columbia, SC, United States | Problems found, fixed voluntarilyFeb 2025 |
| Actavis Pharma, Inc.45 ug · NDC 0591-2927 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Akorn Xopenex0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 0.5 mL, 1.25 mg per 3 mL · NDC 17478-172, 17478-173, 17478-171 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Burel Pharmaceuticals, LLC0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 35573-443, 35573-444, 35573-445 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc. Xopenex Hfa45 ug · NDC 27437-056 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 0.5 mL, 1.25 mg per 3 mL · NDC 0378-9690, 0378-9691, 0378-6993 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.31 mg per 3 mL, 0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 0093-4145, 0093-4146, 0093-4148 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Levalbuterol 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:
50090-6377 - Bryant Ranch Prepack:
72162-2081,72162-2082,72162-2083 - NuCare Pharmaceuticals.Inc.:
68071-2340 - Physicians Total Care, Inc.:
54868-4409,54868-6021,54868-5459,54868-5689 - Proficient Rx LP:
63187-953,63187-876 - Rebel Distributors Corp..:
21695-153 - RedPharm Drug. Inc.:
67296-2271,67296-2304
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.