Antiarrhythmic
Where is Amiodarone made?
22 companies sell it under their own name and 18 repackagers rebottle it. Their labels name 13 factories in India, the United States, Israel, China and Portugal.
India 6United States 4Israel 1China 1Portugal 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AuroMedics Pharma LLC150 mg per 3 mL, 450 mg per 9 mL, 900 mg per 18 mL · NDC 55150-180, 55150-181, 55150-182 | Alivus Life Sciences LimitedMakes the active ingredient | Ankleshwar, India | Problems found, fixed voluntarilyJan 2025 |
| Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 | |
| Advagen Pharma Ltd.100 mg, 200 mg, 400 mg · NDC 72888-060, 72888-039, 72888-061 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 |
| Aurobindo Pharma Limited200 mg · NDC 65862-732 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Baxter Healthcare Corporation Nexterone1.5 mg per 1 mL, 1.8 mg per 1 mL · NDC 43066-150, 43066-360 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Round Lake, IL, United States | Serious problems, FDA actionApr 2026 |
| Cadila Healthcare Limited100 mg, 200 mg, 400 mg · NDC 65841-840, 65841-631, 65841-841 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.100 mg, 200 mg, 300 mg, 400 mg · NDC 51672-4055, 51672-4025, 51672-4056 +1 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Fresenius Kabi USA, LLC50 mg per 1 mL · NDC 65219-643, 65219-645 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi, LLC50 mg per 1 mL · NDC 63323-616 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Gland Pharma Limited50 mg per 1 mL · NDC 68083-112 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hainan Poly Pharm. Co., Ltd.50 mg per 1 mL · NDC 14335-430, 14335-431, 14335-432 | Zhejiang Poly Pharm. Co., LtdMakes it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| Hikma Pharmaceuticals USA Inc.50 mg per 1 mL · NDC 0143-9875 | Hikma Farmaceutica (portugal), S.aMakes it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Mayne Pharma Inc.100 mg, 200 mg, 400 mg · NDC 51862-240, 51862-241, 51862-242 | Catalent Greenville, Inc.Makes it, tests it, packages it and labels it | Greenville, NC, United States | Problems found, fixed voluntarilyOct 2025 |
| Slate Run Pharmaceuticals, LLC.50 mg per 1 mL · NDC 70436-232 | Zhejiang Poly Pharm. Co., LtdMakes it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| Upsher-Smith Laboratories, Inc.100 mg, 200 mg, 400 mg · NDC 0245-0144, 0245-0147, 0245-1645 | Bora Pharmaceuticals Inc.Makes it and packages it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 |
| Wockhardt Limited50 mg per 1 mL · NDC 55648-739, 55648-780 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Zhejiang Poly Pharm. Co., Ltd.50 mg per 1 mL · NDC 72673-071, 72673-072, 72673-073 | Zhejiang Poly Pharm. Co., LtdMakes it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| Zydus Pharmaceuticals (USA) Inc.100 mg, 200 mg, 400 mg · NDC 68382-297, 68382-227, 68382-298 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Cantrell Drug Company1.8 mg per 1 mL · NDC 52533-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.100 mg, 200 mg, 400 mg · NDC 62135-576, 62135-577, 62135-578 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.100 mg, 200 mg, 400 mg · NDC 75907-005, 75907-006, 75907-007 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC50 mg per 1 mL · NDC 67457-153, 72078-046 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.200 mg · NDC 29300-359 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Amiodarone 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:
50090-3496,50090-5766,50090-3015 - American Health Packaging:
60687-437 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-570,71610-787 - AvPAK:
50268-097 - Bryant Ranch Prepack:
72162-2148,71335-1942,71335-1985,71335-0881 - Cardinal Health 107, LLC:
55154-3365,55154-8185 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1480,51662-1481,51662-1363,51662-1358+1 - Henry Schein, Inc.:
0404-9772 - Major Pharmaceuticals:
0904-6993,0904-7576 - Medical Purchasing Solutions, LLC.:
71872-7149,71872-7163,71872-7034,71872-7000+1 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8538,0615-8607,0615-8258 - Physicians Total Care, Inc.:
54868-4618,54868-5186,54868-5722 - ProPharma Distribution:
84549-153 - Rebel Distributors Corp..:
21695-796 - RedPharm Drug. Inc.:
67296-2296 - Remedyrepack Inc.:
70518-3439,70518-1939,70518-3246,70518-1231 - Safecor Health, LLC:
48433-154 - State of Florida DOH Central Pharmacy:
53808-1066
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations - Aug 17, 2020 · Class I · Mylan Institutional LLC
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. - Nov 11, 2019 · Class III · AuroMedics Pharma LLC · 3 recall notices
Crystallization: Presence of visible particulate matter. - Nov 10, 2017 · Class I · Baxter Healthcare Corporation
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged - Sep 12, 2014 · Class II · Mckesson
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.