Opioid Agonist
Where is Methadone made?
15 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 9 factories in the United States.
United States 9
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC5 mg, 10 mg · NDC 67877-116, 67877-660, 67877-659 | Alkem LaboratoriesMakes it | Location not on file | Not inspected on record |
| Havix Group Inc d/b/a Aavis PharmaceuticalsMakes it, tests it and packages it | Hoschton, GA, United States | Problems found, fixed voluntarilyJul 2025 | |
| Hikma Pharmaceuticals USA Inc. Diskets5 mg, 5 mg per 5 mL, 10 mg, 10 mg per 1 mL, 10 mg per 5 mL, 40 mg · NDC 0054-0710, 0054-0392, 0054-0391 +5 | Siegfried USA, LLCMakes the active ingredient | Pennsville, NJ, United States | No problems foundSep 2025 |
| West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 | |
| SpecGx LLC Methadose, Methadosesugar-Free5 mg, 5 mg per 5 mL, 10 mg, 10 mg per 1 mL, 10 mg per 5 mL, 40 mg · NDC 0406-5771, 0406-0527, 0406-8725 +6 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| SpecGx LLCMakes the active ingredient and tests it | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| Akorn10 mg per 1 mL · NDC 17478-380 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Aurolife Pharma LLC5 mg, 10 mg · NDC 13107-089, 13107-088 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Breckenridge Pharmaceutical, Inc.10 mg per 1 mL · NDC 51991-002 | Siegfried USA, LLCMakes the active ingredient and tests it | Pennsville, NJ, United States | No problems foundSep 2025 |
| Camber Pharmaceuticals Inc.5 mg, 10 mg · NDC 31722-947, 31722-946 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Elite Laboratories, Inc.5 mg, 10 mg · NDC 64850-604, 64850-603 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Epic Pharma, LLC5 mg, 10 mg · NDC 42806-318, 42806-317 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| XLCare Pharmaceuticals, Inc.5 mg, 10 mg · NDC 72865-121, 72865-120 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Hikma Pharmaceuticals USA Inc.10 mg per 1 mL · NDC 0641-6266 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.10 mg per 1 mL · NDC 0527-1927 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Long Grove Pharmaceuticals, LLC200 mg per 20 mL · NDC 81298-7500 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC Methadone Hydrochloride10 mg per 1 mL · NDC 67457-217 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VistaPharm, LLC5 mg per 5 mL, 10 mg, 10 mg per 1 mL, 40 mg · NDC 66689-836, 66689-820, 66689-694 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Methadone 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:
60687-910,60687-818 - Atlantic Biologicals Corps.:
17856-3553,17856-1929,17856-1928,17856-0694+7 - Bryant Ranch Prepack:
71335-1360,63629-2098,72162-1085 - Direct Rx:
61919-670 - H.J. Harkins Co., Inc.:
52959-386,52959-435 - Lake Erie Medical DBA Quality Care Products LLC:
49999-839 - Lohxa:
70166-284 - Major Pharmaceuticals:
0904-7417 - Physicians Total Care, Inc.:
54868-4948,54868-5701 - Precision Dose Inc.:
68094-331,68094-031 - Stat Rx USA:
42549-578,16590-689,42549-577
Recalls
- Dec 19, 2024 · Class III · West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. - Jan 18, 2017 · Class II · VistaPharm, Inc. · 3 recall notices
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.