beta-Adrenergic Blocker
Where is Labetalol made?
31 companies sell it under their own name and 20 repackagers rebottle it. Their labels name 13 factories in India and the United States.
India 10United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Pharma Inc.100 mg, 200 mg, 300 mg, 400 mg · NDC 70377-060, 70377-061, 70377-062 +1 | Appco Pharma LLCMakes it, tests it and packages it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Piramal Pharma LimitedMakes it, tests it and packages it | Pithampur, India | No problems foundMay 2023 | |
| BluePoint Laboratories.100 mg, 200 mg, 300 mg · NDC 68001-381, 68001-700, 68001-382 +3 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it, packages it and labels it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 | |
| Hospira, Inc.5 mg per 1 mL · NDC 0409-2339, 0409-2267, 0409-0125 | Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 |
| Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 | |
| Northstar Rx LLC.5 mg per 1 mL, 100 mg, 200 mg, 300 mg · NDC 72603-902, 72603-903, 72603-904 +1 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it, packages it and labels it | East Brunswick, NJ, United States | No problems foundSep 2023 | |
| Advagen Pharma Ltd.100 mg, 200 mg, 300 mg · NDC 72888-120, 72888-121, 72888-468 +1 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 |
| Akorn5 mg per 1 mL · NDC 17478-420 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Amneal Pharmaceuticals LLC5 mg per 1 mL · NDC 70121-2428 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Baxter Healthcare Corporation5 mg per 1 mL · NDC 36000-320, 36000-322, 36000-324 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Cadila Healthcare Limited100 mg, 200 mg, 300 mg · NDC 70771-1163, 70771-1164, 70771-1165 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Cadila Pharmaceuticals Limited100 mg, 200 mg, 300 mg · NDC 71209-083, 71209-084, 71209-085 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Caplin Steriles Limited5 mg per 1 mL · NDC 65145-124, 65145-125 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited5 mg per 1 mL · NDC 68083-111 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.100 mg, 200 mg, 300 mg, 400 mg · NDC 23155-723, 23155-724, 23155-725 +1 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it, packages it and labels it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Macleods Pharmaceuticals Limited100 mg, 200 mg, 300 mg · NDC 33342-515, 33342-516, 33342-517 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Dhar, India | Problems found, fixed voluntarilyAug 2024 |
| Mullan Pharmaceutical Inc.100 mg per 20 mL, 200 mg per 40 mL · NDC 83301-0058, 83301-0059 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Onesource Specialty Pharma Limited5 mg per 1 mL · NDC 83270-178, 83270-179 | Onesource Specialty Pharma LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Zydus Pharmaceuticals (USA) Inc.100 mg, 200 mg, 300 mg · NDC 68382-798, 68382-799, 68382-800 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Actavis Pharma, Inc.100 mg, 200 mg, 300 mg · NDC 0591-0605, 0591-0606, 0591-0607 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.100 mg per 20 mL · NDC 72485-515 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cantrell Drug Company5 mg per 1 mL · NDC 52533-034 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.100 mg, 200 mg, 300 mg · NDC 62135-791, 62135-792, 62135-800 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.5 mg per 1 mL · NDC 72572-350 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Epic Pharma, LLC100 mg, 200 mg, 300 mg · NDC 42806-327, 42806-328, 42806-329 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.5 mg per 1 mL · NDC 72266-103, 72266-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc. Labetalol HCl in Sodium Chloride, Labetalol HCl in Dextrose, Labetalol Hydrochloride1 mg per 1 mL, 5 mg per 1 mL · NDC 0143-9363, 0143-9364, 0143-9365 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Innogenix, Inc.100 mg, 200 mg, 300 mg · NDC 71247-126, 71247-127, 71247-130 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.100 mg, 200 mg, 300 mg · NDC 10135-711, 10135-712, 10135-713 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.100 mg, 200 mg, 300 mg · NDC 58657-906, 58657-602, 58657-603 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prometheus Laboratories Inc. Trandate100 mg, 200 mg, 300 mg · NDC 65483-391, 65483-392, 65483-393 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 1 mL · NDC 25021-317 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.100 mg, 200 mg, 300 mg · NDC 29300-252, 29300-253, 29300-254 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Labetalol 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:
50090-3584,50090-4149,50090-6741,50090-1161+16 - American Health Packaging:
60687-439,60687-450,60687-461 - Bryant Ranch Prepack:
63629-1161,63629-1162,71335-3065,72162-1675+14 - Cardinal Health 107, LLC:
55154-0181,55154-8192,55154-0182,55154-2143+2 - Coupler LLC:
67046-1042,67046-1693,67046-1148,67046-1697+1 - Dispensing Solutions Inc.:
68258-6047 - Golden State Medical Supply, Inc.:
51407-614,51407-615,51407-616 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1228,51662-1602 - Major Pharmaceuticals:
0904-7451,0904-7452,0904-7453 - Marlex Pharmaceuticals, Inc.:
10135-641,10135-642,10135-643 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8512,0615-8513 - Northwind Pharmaceuticals:
51655-322 - NuCare Pharmaceuticals.Inc.:
68071-3878 - Physicians Total Care, Inc.:
54868-4921,54868-4844,54868-4903 - Proficient Rx LP:
71205-095,82804-289 - Rebel Distributors Corp..:
21695-592,21695-994,21695-988 - RedPharm Drug. Inc.:
67296-2156,67296-2114 - Remedyrepack Inc.:
70518-3499,70518-4201,70518-3993 - St. Mary's Medical Park Pharmacy:
60760-784,60760-991 - Stat Rx USA:
16590-994
Recalls
- May 20, 2024 · Class II · Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals. - Feb 20, 2018 · Class II · Hospira Inc. A Pfizer Company
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. - May 16, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.