Anti-epileptic Agent
Where is Ethosuximide made?
11 companies sell it under their own name and 1 repackager rebottle it. Their labels name 7 factories in the United States, Switzerland, China and India.
United States 4Switzerland 1China 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn250 mg · NDC 61748-025 | Swiss Caps AGMakes it | Kirchberg, Switzerland | Problems found, fixed voluntarilyJun 2023 |
| Banner Life Sciences LLC.250 mg · NDC 69387-108 | Banner Pharmacaps IncMakes it | Location not on file | Not inspected on record |
| Bionpharma Inc.250 mg · NDC 69452-152 | Patheon Softgels Inc.Makes it | High Point, NC, United States | Problems found, fixed voluntarilyJul 2025 |
| Epic Pharma, LLC250 mg · NDC 42806-708, 42806-711 | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdMakes it | Wuhan, China | Problems found, fixed voluntarilyMar 2025 |
| Mylan Pharmaceuticals Inc.250 mg per 5 mL · NDC 59762-2350 | Pharmacia & Upjohn Company LLCMakes it, tests it, packages it and labels it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Parke-Davis Div of Pfizer Inc Zarontin250 mg, 250 mg per 5 mL · NDC 0071-0237, 0071-2418 | Pharmacia & Upjohn Company LLCMakes it, tests it and packages it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Pharmaceutical Associates, Inc.250 mg per 5 mL · NDC 0121-0670 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| Strides Pharma Science Limited250 mg · NDC 64380-878 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Zydus Pharmaceuticals (USA) Inc.250 1 · NDC 68382-443 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it and tests it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Chartwell Governmental & Specialty RX, LLC.250 mg per 5 mL · NDC 68999-064 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.250 mg, 250 mg per 5 mL · NDC 62135-790, 62135-064 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ethosuximide 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.
- Bryant Ranch Prepack:
63629-8005
Recalls
- Jul 29, 2021 · Class II · PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. - Sep 12, 2019 · Class III · Pfizer Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. - Aug 24, 2018 · Class II · Akorn, Inc.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.