Leukotriene Receptor Antagonist
Where is Montelukast made?
22 companies sell it under their own name and 28 repackagers rebottle it. Their labels name 17 factories in India, the United States and China.
India 13United States 3China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited4 mg, 5 mg, 10 mg · NDC 65862-574, 59651-329, 65862-567 +1 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Aurolife Pharma LLCMakes it and tests it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Accord Healthcare Inc.10 mg · NDC 16729-119 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Ajanta Pharma USA Inc.4 mg, 5 mg, 10 mg · NDC 27241-018, 27241-015, 27241-016 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 | |
| Hikma Pharmaceuticals USA Inc.4 mg, 5 mg, 10 mg · NDC 0143-9649, 0143-9651, 0143-9650 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Kemwell Biopharma Private LimitedMakes it, tests it and packages it | Location not on file | Not inspected on record | |
| Rising Pharma Holdings, Inc.4 mg, 5 mg, 10 mg · NDC 16571-100, 57237-255, 57237-212 +1 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 | |
| Torrent Pharma, Inc.4 mg, 4 mg per 500 mg, 5 mg, 10 mg · NDC 13668-081, 13668-079, 13668-531 +1 | Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Amneal Pharmaceuticals4 mg, 5 mg, 10 mg · NDC 65162-732, 65162-771, 65162-772 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| BluePoint Laboratories.10 mg · NDC 68001-361 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Camber Pharmaceuticals Inc.4 mg, 5 mg, 10 mg · NDC 31722-726, 31722-727, 31722-728 | Hetero Labs LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Dr.Reddy's Laboratories Ltd.4 mg, 5 mg, 10 mg · NDC 55111-725, 55111-763, 55111-593 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.4 mg, 5 mg, 10 mg · NDC 60723-010, 60723-004, 60723-005 | Hangzhou Minsheng Binjiang Pharmaceutical Co.,LtdMakes it | Hangzhou, China | Serious problems, FDA actionMar 2025 |
| Macleods Pharmaceuticals Limited4 mg, 5 mg, 10 mg · NDC 33342-102, 33342-110, 33342-111 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Quallent Pharmaceuticals Health LLC10 mg · NDC 82009-009 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Westminster Pharmaceuticals, LLC10 mg · NDC 69367-287 | Hangzhou Minsheng Binjiang Pharmaceutical Co.,LtdMakes it | Hangzhou, China | Serious problems, FDA actionMar 2025 |
| XLCare Pharmaceuticals, Inc.10 mg · NDC 72865-175 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| AvKARE, Inc.10 mg · NDC 42291-621 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvPAK10 mg · NDC 50268-575 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.4 mg, 5 mg · NDC 62135-781, 62135-782 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.4 mg, 5 mg · NDC 62175-204, 62175-205 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Singulair4 mg, 5 mg, 10 mg · NDC 78206-172, 78206-171, 78206-170 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.10 mg · NDC 0781-5560 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.4 mg, 5 mg, 10 mg · NDC 29300-220, 29300-221, 29300-222 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Montelukast 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:
50090-4919,50090-2480,50090-6108,50090-6109+5 - Aidarex Pharmaceuticals LLC:
33261-969,53217-357 - American Health Packaging:
68084-875 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-879,71610-051,71610-129,71610-563 - AvKARE, Inc.:
42291-622,42291-623 - AvPAK:
50268-556,50268-573,50268-574 - Bryant Ranch Prepack:
63629-8106,71335-0514,71335-1995,71335-1979+2 - Cardinal Health 107, LLC:
55154-8075 - Carilion Materials Management:
68151-3498,68151-3494,68151-4338,68151-4186 - Coupler Enterprises Inc.:
67046-468 - Coupler LLC:
67046-1357,67046-0468,67046-2060 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-485 - Direct Rx:
61919-009,72189-418,61919-097,72189-223 - Dispensing Solutions Inc.:
68258-3033,68258-3032 - International Laboratories, LLC:
54458-890 - Major Pharmaceuticals:
0904-6808 - MedVantx, Inc.:
66116-503 - NuCare Pharmaceuticals.Inc.:
68071-2846,68071-1561,68071-3355,68071-4034+3 - PD-Rx Pharmaceuticals, Inc.:
72789-306,43063-762,43063-381 - Physicians Total Care, Inc.:
54868-3283,54868-6361,54868-4630,54868-6363+2 - Preferred Pharmaceuticals, Inc..:
68788-8617,68788-8610,68788-8099,68788-7669 - Proficient Rx LP:
63187-430,63187-692,63187-781,71205-181+7 - RPK Pharmaceuticals, Inc.:
53002-1441,53002-6441,53002-5441,53002-4441+1 - ReadyMeds:
64205-655 - Rebel Distributors Corp..:
21695-221,42254-263,21695-565 - RedPharm Drug. Inc.:
67296-1926,67296-2248,67296-1381,67296-1482 - Remedyrepack Inc.:
70518-3133,70518-4753 - State of Florida DOH Central Pharmacy:
53808-0690,53808-0920,53808-0995
Recalls
- Oct 13, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg. - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection. - Jan 20, 2020 · Class III · Macleods Pharma Usa Inc
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product - Aug 20, 2018 · Class II · Hetero Labs Limited Unit V
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. - Aug 15, 2018 · Class I · Hetero Labs Limited Unit V
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. - Jan 7, 2017 · Class III · Hetero USA Inc
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.