Anti-epileptic Agent
Where is Primidone made?
13 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 7 factories in India, the United States and Canada.
India 3United States 3Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bausch Health US, LLC Mysoline50 mg, 250 mg · NDC 66490-691, 66490-690 | Bausch Health Companies Inc.Makes it, packages it and labels it | Steinbach, Canada | No problems foundMay 2023 |
| Piramal Pharma LimitedMakes it | Pithampur, India | No problems foundMay 2023 | |
| Advagen Pharma Ltd.50 mg, 125 mg, 250 mg · NDC 72888-160, 72888-046, 72888-045 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Carnegie Pharmaceuticals, LLC50 mg, 250 mg · NDC 80005-118, 80005-117 | Carnegie Pharmaceuticals, LLCMakes it | Delran, NJ, United States | No problems foundOct 2025 |
| Dr.Reddy's Laboratories Ltd.50 mg, 250 mg · NDC 55111-476, 55111-477 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lannett Company, Inc.50 mg, 250 mg · NDC 0527-1231, 0527-1301 | Lannett Company, LLCMakes it, tests it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Northstar Rx LLC.50 mg, 250 mg · NDC 72603-610, 72603-609 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Oxford Pharmaceuticals, LLC50 mg, 250 mg · NDC 69584-685, 69584-684 | Oxford Pharmaceuticals, LLCMakes it | Birmingham, AL, United States | Problems found, fixed voluntarilyNov 2023 |
| TruPharma LLC.125 mg · NDC 52817-117 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Actavis Pharma, Inc.250 mg · NDC 0591-5321 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals50 mg, 250 mg · NDC 65162-545, 53746-545, 65162-544 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.50 mg · NDC 42291-509 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.50 mg · NDC 62135-468 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.50 mg, 250 mg · NDC 10135-522, 10135-540 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Primidone 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:
50090-1622 - American Health Packaging:
68084-203,68084-202 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-590,71610-540,71610-763 - AvKARE, Inc.:
42291-511 - AvPAK:
50268-687,50268-686 - Bryant Ranch Prepack:
71335-1158,71335-1965,63629-7811 - Direct Rx:
72189-216 - Golden State Medical Supply, Inc.:
51407-638,51407-637 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8206,0615-8664 - PD-Rx Pharmaceuticals, Inc.:
72789-177,72789-178 - Physicians Total Care, Inc.:
54868-1691,54868-5067 - Proficient Rx LP:
82804-953,82804-952 - Stat Rx USA:
42549-680
Recalls
- Jun 3, 2026 · Class III · Amneal Pharmaceuticals, LLC
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. - May 1, 2026 · Class III · Amerisource Health Services LLC · 2 recall notices
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Apr 27, 2026 · Class III · Golden State Medical Supply Inc. · 2 recall notices
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Apr 24, 2026 · Class III · Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.