Anti-epileptic Agent
Where is Phenytoin made?
20 companies sell it under their own name and 29 repackagers rebottle it. Their labels name 13 factories in the United States, India, Israel and Portugal.
United States 6India 5Israel 1Portugal 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals50 mg per 1 mL, 100 mg · NDC 65162-212, 65162-998, 65162-999 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Hauppauge, NY, United States | No problems foundFeb 2020 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 | |
| Caraco Pharmaceutical Laboratories, Ltd.50 mg, 100 mg, 125 mg per 5 mL, 200 mg, 300 mg · NDC 51672-4111, 51672-4069, 62756-299 +2 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| Aurobindo Pharma Limited100 mg · NDC 65862-692 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Fresenius Kabi, LLC50 mg per 1 mL · NDC 63323-403 | 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 68083-460, 68083-461 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Glenmark Pharmaceuticals Inc., USA50 mg per 1 mL · NDC 68462-621, 68462-622, 68462-945 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc.50 mg per 1 mL · NDC 0143-9788, 0143-9782 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hikma Pharmaceuticals USA Inc.50 mg per 1 mL · NDC 0641-0493, 0641-2555, 0641-6138 +3 | Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Lifestar Pharma LLC.100 mg · NDC 70756-446 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Parke-Davis Div of Pfizer Inc50 mg · NDC 0071-0007 | Pharmacia & Upjohn Company LLCMakes the active ingredient and tests it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Pfizer Laboratories Div Pfizer Inc Cerebyx50 mg per 1 mL · NDC 0069-5474, 0069-5471, 0069-6001 | Pharmacia & Upjohn Company LLCMakes it, makes the active ingredient, tests it, packages it and labels it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Prasco Laboratories50 mg · NDC 66993-372 | Pharmacia & Upjohn Company LLCMakes the active ingredient and tests it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
| Rising Pharma Holdings, Inc.50 mg · NDC 64980-573 | Appco Pharma LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Wockhardt Limited100 mg · NDC 55648-720 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Acella Pharmaceuticals, LLC50 mg per 1 mL · NDC 42192-614 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.100 mg · NDC 10135-603 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.125 mg per 5 mL, 200 mg, 300 mg · NDC 59762-0531, 0378-2670, 0378-3750 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 1 mL · NDC 25021-798 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.100 mg · NDC 29300-379 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Dilantin-12530 mg, 100 mg, 125 mg per 5 mL · NDC 58151-110, 58151-115, 58151-118 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Phenytoin 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:
50090-0029,50090-5700,50090-3539 - American Health Packaging:
60687-841,60687-275,60687-156 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-131,67544-517,71610-869,71610-934 - Atlantic Biologicals Corps.:
17856-0067,17856-4070 - AvPAK:
50268-719 - Avera McKennan Hospital:
69189-3742 - Bryant Ranch Prepack:
72162-2514 - Carilion Materials Management:
68151-1019 - Coupler Enterprises Inc.:
67046-585 - Coupler LLC:
67046-0585,67046-1486 - Direct Rx:
61919-815 - Golden State Medical Supply, Inc.:
51407-982 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1250,51662-1251 - Henry Schein, Inc.:
0404-9932,0404-9808 - Major Pharmaceuticals:
0904-7416,0904-7199 - Medical Purchasing Solutions, LLC.:
71872-7079 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8556,0615-8424,0615-8623 - PD-Rx Pharmaceuticals, Inc.:
43063-492 - Pharmaceutical Associates, Inc.:
0121-0892 - Physicians Total Care, Inc.:
54868-0325,54868-5534,54868-2038,54868-1486 - ProPharma Distribution:
84549-093 - Proficient Rx LP:
82804-269 - RPK Pharmaceuticals, Inc.:
53002-2501,53002-4501,53002-1501 - Rebel Distributors Corp..:
21695-167 - RedPharm Drug. Inc.:
67296-1251 - Remedyrepack Inc.:
70518-2293,70518-2227,70518-0107,70518-0980+2 - Stat Rx USA:
16590-815 - State of Florida DOH Central Pharmacy:
53808-0652,53808-1040 - TYA Pharmaceuticals:
64725-0720,64725-4111
Recalls
- Oct 27, 2023 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications - May 30, 2023 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) - Nov 14, 2022 · Class III · Acella Pharmaceuticals, LLC · 2 recall notices
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. - Feb 7, 2020 · Class I · Taro Pharmaceuticals U.S.A., Inc.
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. - May 2, 2014 · Class II · Fresenius Kabi USA, LLC · 2 recall notices
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. - Aug 17, 2013 · Class II · Amneal Pharmaceuticals of New York, LLC.
Failed dissolution specifications; 18 month CRT - Apr 13, 2012 · Class II · West-ward Pharmaceutical Corp. · 2 recall notices
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.