Skeletal Muscle Relaxant
Where is Dantrolene made?
7 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 8 factories in the United States, India, Taiwan, Switzerland and Italy.
United States 3India 2Taiwan 1Switzerland 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Uswm, LLC20 mg per 60 mL · NDC 78670-003 | HAS Healthcare Advanced Synthesis SAMakes the active ingredient | Biasca, Switzerland | No problems foundFeb 2025 |
| Patheon Italia S.p.AMakes it, tests it, packages it and labels it | Ferentino, Italy | Problems found, fixed voluntarilyFeb 2022 | |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Eagle Pharmaceuticals, Inc. RYANODEX dantrolene sodium250 mg per 5 mL · NDC 42367-540 | Alcami Carolinas CorporationMakes it | Charleston, SC, United States | Problems found, fixed voluntarilyFeb 2026 |
| ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 | |
| Amneal Pharmaceuticals25 mg, 50 mg, 100 mg · NDC 0115-4433, 0115-4411, 0115-4422 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Elite Laboratories, Inc.25 mg, 50 mg, 100 mg · NDC 64850-842, 64850-840, 64850-841 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Par Health USA, LLC Dantrium25 mg, 50 mg, 100 mg · NDC 49884-364, 42023-126, 49884-362 +3 | Par Formulations Private LimitedMakes it, tests it and packages it | Chennai, India | Problems found, fixed voluntarilyJun 2026 |
| ENDO USA, Inc. Dantrium20 mg per 60 mL · NDC 42023-123 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.20 mg · NDC 0143-9297 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dantrolene 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.
- American Health Packaging:
68084-300 - AvPAK:
50268-217 - Bryant Ranch Prepack:
72162-2047,72162-1497,63629-2168,72162-2045+2 - Cardinal Health 107, LLC:
55154-7140 - Carilion Materials Management:
68151-1520 - Major Pharmaceuticals:
0904-7211 - ProPharma Distribution:
84549-003 - Remedyrepack Inc.:
70518-4622,70518-4668
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.