beta-Adrenergic Blocker
Where is Esmolol made?
9 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 6 factories in India and the United States.
India 3United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals LLC10 mg per 1 mL, 20 mg per 1 mL · NDC 70121-1716, 70121-1717 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Mehsana, India | Not inspected on record |
| AuroMedics Pharma LLC10 mg per 1 mL, 20 mg per 1 mL, 100 mg per 10 mL · NDC 55150-420, 55150-194, 55150-421 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Baxter Healthcare Corporation Brevibloc, Esmolol Hydrochloride10 mg per 1 mL, 20 mg per 1 mL · NDC 10019-115, 10019-055, 10019-670 +5 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Marion, NC, United States | Serious problems, FDA actionFeb 2024 |
| Fresenius Kabi, LLC10 mg per 1 mL · NDC 63323-661, 63323-652 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-211 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc. Esmolol Hydrochloride10 mg per 1 mL · NDC 0641-2965 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it, labels it and sterilizes it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Mylan Institutional LLC10 mg per 1 mL, 20 mg per 1 mL · NDC 67457-182, 67457-657, 67457-658 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL, 20 mg per 1 mL · NDC 25021-308, 25021-309 | The label doesn't name the factory. Plants this company names for other drugs | ||
| WG Critical Care, LLC. Esmolol Hydrochloride in Water10 mg per 1 mL, 20 mg per 1 mL · NDC 44567-450, 44567-811, 44567-451 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Esmolol 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:
50090-4699,50090-4512 - General Injectables & Vaccines, Inc.:
52584-017 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1371,51662-1322,51662-1427,51662-1444 - Henry Schein, Inc.:
0404-9825,0404-9785,0404-9858 - Medical Purchasing Solutions, LLC.:
71872-7136,71872-7049 - ProPharma Distribution:
84549-194 - Remedyrepack Inc.:
70518-4410
Recalls
- Apr 12, 2016 · Class II · Baxter Healthcare Corp.
Discoloration: presence of atypical yellow discoloration of the solution . - Jun 16, 2014 · Class II · Baxter Healthcare Corp.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.