Histamine-1 Receptor Antagonist
Where is Azelastine made?
15 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 8 factories in India and the United States.
India 6United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.0.5 mg per 1 mL · NDC 62332-506 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Akorn1.5 mg per 1 mL · NDC 50383-942 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Limited0.5 mg per 1 mL · NDC 46708-506 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals1 mg per 1 mL · NDC 65162-676 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 |
| Ascend Laboratories, LLC137 ug · NDC 67877-477 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited137 ug · NDC 59651-214 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg per 1 mL, 137 ug · NDC 47335-938, 47335-779 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Gland Pharma Limited0.5 mg per 1 mL · NDC 68083-287 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| H.J. Harkins Co., Inc.137 ug per 0.137 mL · NDC 76519-1222 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Northstar Rx LLC.137 ug · NDC 72603-611 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Somerset Therapeutics, LLC0.5 mg per 1 mL · NDC 70069-091 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Apotex Corp.0.5 mg per 1 mL, 137 ug · NDC 60505-0578, 60505-0833 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.1 mg per 1 mL · NDC 42291-094 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.0.5 mg per 1 mL · NDC 72266-141 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.0.5 mg per 1 mL · NDC 61314-308 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Azelastine 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:
50090-3833,50090-2330,50090-7461 - NuCare Pharmaceuticals.Inc.:
68071-2497,68071-2498 - Physicians Total Care, Inc.:
54868-5072,54868-6131 - Preferred Pharmaceuticals, Inc..:
68788-4056,68788-8514 - Proficient Rx LP:
71205-449 - RPK Pharmaceuticals, Inc.:
53002-1803,53002-2279,53002-5279,53002-1279
Recalls
- May 28, 2025 · Class II · Apotex Corp.
Lack of Assurance of Sterility - Feb 5, 2018 · Class III · Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station - Jun 15, 2011 · Class III · Apotex Corp.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.