beta2-Adrenergic Agonist
Where is Albuterol made?
30 companies sell it under their own name and 28 repackagers rebottle it. Their labels name 20 factories in the United States, India, China, Ireland, Hungary and the United Kingdom.
United States 9India 6China 2Ireland 1Hungary 1United Kingdom 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.83 mg per 1 mL, 2 mg, 4 mg · NDC 47335-703, 53489-176, 53489-177 | ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo ReszvenytarsasagMakes it | Tiszavasvari, Hungary | Problems found, fixed voluntarilyMar 2025 |
| Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 | |
| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 | |
| Cipla USA., Inc.90 ug · NDC 69097-142, 69097-021 | Cipla LimitedMakes it, tests it, packages it and labels it | Indore, India | Serious problems, FDA actionFeb 2023 |
| Cipla LimitedMakes the active ingredient and tests it | Raigad, India | Problems found, fixed voluntarilyApr 2024 | |
| InvaGen Pharmaceuticals Inc.Makes it, tests it, packages it and labels it | Fall River, MA, United States | No problems foundMay 2023 | |
| Amneal Pharmaceuticals2 mg, 4 mg, 90 ug · NDC 69238-1344, 69238-1345, 69238-1291 | Amneal Ireland LimitedMakes it, tests it, packages it and labels it | Cashel, Ireland | Problems found, fixed voluntarilyFeb 2024 |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 | |
| Aurobindo Pharma Limited0.63 mg per 3 mL, 0.83 mg per 1 mL, 1.25 mg per 3 mL, 2 mg, 4 mg · NDC 59651-183, 65862-858, 59651-184 +2 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.Makes it and tests it | Chengdu, China | Not inspected on record | |
| Merck Sharp & Dohme Corp. Proventil HFA108 ug · NDC 0085-1132 | 3M Health Care LTDMakes it | Location not on file | Not inspected on record |
| Kindeva Drug Delivery L.P.Makes it | Northridge, CA, United States | Problems found, fixed voluntarilyNov 2025 | |
| Rising Pharma Holdings, Inc.0.63 mg per 3 mL, 1.25 mg per 3 mL, 2 mg, 2.5 mg per 0.5 mL, 2.5 mg per 3 mL, 4 mg · NDC 64980-643, 64980-644, 64980-442 +3 | Appco Pharma LLCMakes it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 | |
| Sandoz Inc.108 ug · NDC 0781-7296 | Kindeva Drug Delivery L.P.Makes it, tests it, packages it and labels it | Northridge, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Kindeva Drug Delivery LimitedMakes it | Loughborough, United Kingdom | Problems found, fixed voluntarilyMar 2025 | |
| Akorn2 mg per 5 mL · NDC 50383-740 | AkornMakes it | Location not on file | Not inspected on record |
| Armstrong Pharmaceuticals, Inc.90 ug · NDC 17270-0740 | Armstrong Pharmaceuticals, Inc.Makes it, tests it, packages it, labels it and mills it | Canton, MA, United States | Problems found, fixed voluntarilyMay 2026 |
| Cadila Healthcare Limited2 mg, 4 mg · NDC 70771-1511, 70771-1512 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Exelan Pharmaceuticals, Inc.90 ug · NDC 76282-679 | Cipla LimitedMakes the active ingredient and tests it | Raigad, India | Problems found, fixed voluntarilyApr 2024 |
| H.J. Harkins Co., Inc. Albuterol Sulfatehfa90 ug per 1 g · NDC 76519-1171, 76519-1175 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Ingenus Pharmaceuticals, LLC0.63 mg per 3 mL, 1.25 mg per 3 mL · NDC 50742-392, 50742-393 | Lexenpharm (Suzhou) LimitedMakes it, tests it, packages it and labels it | Suzhou, China | Problems found, fixed voluntarilySep 2025 |
| Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.0.63 mg per 3 mL, 0.83 mg per 1 mL, 1.25 mg per 3 mL · NDC 81894-105, 81894-104, 81894-106 | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.Makes it and tests it | Chengdu, China | Not inspected on record |
| Nephron Pharmaceuticals Corporation0.63 mg per 3 mL, 1.25 mg per 3 mL, 2.5 mg per 0.5 mL, 2.5 mg per 3 mL · NDC 0487-0301, 0487-9904, 0487-9901 +1 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Praxis, LLC90 ug, 108 ug · NDC 59368-412, 59368-401 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| Quagen Pharmaceuticals LLC2 mg per 5 mL · NDC 70752-102 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Zydus Pharmaceuticals (USA) Inc.2 mg, 4 mg · NDC 70710-1061, 70710-1062 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| American Health Packaging2.5 mg per 3 mL, 90 ug · NDC 60687-395, 60687-662 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.2 mg per 5 mL · NDC 68999-189 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.0.63 mg per 3 mL, 1.25 mg per 3 mL, 2 mg, 2 mg per 5 mL, 2.5 mg per 0.5 mL, 2.5 mg per 3 mL · NDC 62135-826, 62135-827, 62135-671 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| GlaxoSmithKline LLC Ventolinhfa90 ug · NDC 0173-0682 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.90 ug · NDC 0054-0742 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.90 ug · NDC 68180-963 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.63 mg per 3 mL, 1.25 mg per 3 mL, 2.5 mg per 3 mL · NDC 0378-7057, 0378-7058, 0378-8270 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd90 ug · NDC 45802-088 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories90 ug · NDC 66993-019 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ritedose Pharmaceuticals, LLC0.63 mg per 3 mL, 1.25 mg per 3 mL, 2.5 mg per 0.5 mL, 2.5 mg per 3 mL · NDC 76204-010, 76204-011, 76204-027 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.90 ug · NDC 0093-3174 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Respiratory, LLC ProAir Digihaler, ProAir RespiClick90 ug · NDC 59310-540, 59310-117, 59310-580 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Albuterol 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:
50090-4326,50090-6560,50090-0516,50090-4977+8 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0359,80425-0266 - Aidarex Pharmaceuticals LLC:
33261-789 - American Health Packaging:
68084-949,68084-952 - Asclemed USA, Inc.:
76420-087,87063-031,76420-531,76420-088+1 - Atlantic Biologicals Corps.:
17856-0740 - Bryant Ranch Prepack:
72162-2064,71335-2907,63629-2611 - Cardinal Health 107, LLC:
55154-2132,55154-4410 - Carilion Materials Management:
68151-0661 - Direct Rx:
72189-002,72189-022,72189-016 - Dispensing Solutions Inc.:
68258-3037,68258-8001 - Golden State Medical Supply, Inc.:
51407-367,51407-368 - H.J. Harkins Co., Inc.:
52959-983,52959-978 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1499,51662-1513,51662-1267 - Hawaii Repack, Inc.:
85534-0039 - Medical Purchasing Solutions, LLC.:
71872-7054 - NuCare Pharmaceuticals.Inc.:
68071-2656,68071-2679,68071-2505,68071-3780+10 - Physicians Total Care, Inc.:
54868-5709,54868-6051,54868-6050,54868-2887+4 - Preferred Pharmaceuticals, Inc..:
68788-8492,68788-7996,68788-7573,68788-8399+5 - Proficient Rx LP:
71205-641,82804-036,71205-898,63187-204+6 - RPK Pharmaceuticals, Inc.:
53002-1557,53002-1584,53002-1551,53002-1750+2 - Rebel Distributors Corp..:
21695-423,42254-004,21695-350,21695-332+3 - RedPharm Drug. Inc.:
67296-1867,67296-2338,67296-1863,67296-1348+3 - Remedyrepack Inc.:
70518-3560,70518-4490,70518-4528,70518-2072+4 - Sportpharm LLC:
85766-127,85766-062,85766-055,85766-020 - Stat Rx USA:
16590-339 - TYA Pharmaceuticals:
64725-5790 - Unit Dose Services:
50436-6050
Recalls
- Jul 24, 2025 · Class III · Cipla USA, Inc.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. - Jun 27, 2023 · Class I · Cipla USA, Inc.
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office · 5 recall notices
cGMP deviations: Temperature abuse - Jan 26, 2022 · Class II · Cardinal Healthcare · 2 recall notices
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Sep 16, 2020 · Class II · Perrigo Company PLC
Defective Delivery System: Sustained trend of failure to dispense complaints. - May 16, 2017 · Class II · GlaxoSmithKline, LLC
Defective Delivery System: Elevated number of units with out of specification results for leak rate - Mar 22, 2017 · Class II · GlaxoSmithKline, LLC
Defective Delivery System: Elevated number of units with out of specification results for leak rate. - Dec 3, 2015 · Class II · GlaxoSmithKline, LLC
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. - Oct 2, 2013 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. - Jul 26, 2012 · Class II · GlaxoSmithKline Inc
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. - Jun 22, 2011 · Class II · Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.