Prescription drug
Where is Phenobarbital made?
24 companies sell it under their own name and 15 repackagers rebottle it. Their labels name 13 factories in the United States and India.
United States 12India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BPI Labs, LLC20 mg per 5 mL, 65 mg per 1 mL, 130 mg per 1 mL · NDC 54288-137, 54288-163, 54288-136 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| BPI Labs LLCMakes it and tests it | Largo, FL, United States | Problems found, fixed voluntarilyApr 2025 | |
| Caraco Pharmaceutical Laboratories, Ltd. Sezaby15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg · NDC 51672-5334, 62756-301, 51672-5331 +6 | Genus Lifesciences Inc.Makes it, packages it and labels it | Allentown, PA, United States | No problems foundJul 2024 |
| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 | |
| ENDO USA, Inc.16.2 mg, 32.4 mg, 64.8 mg, 97.2 mg · NDC 0603-5165, 0603-5166, 0603-5167 +1 | Generics Bidco II LLC d/b/a Prinston LaboratoriesMakes it, packages it and labels it | Charlotte, NC, United States | Problems found, fixed voluntarilySep 2025 |
| Generics Bidco II LLC d/b/a Prinston LaboratoriesMakes it and tests it | Charlotte, NC, United States | Problems found, fixed voluntarilySep 2025 | |
| Ajenat Pharmaceuticals LLC20 mg per 5 mL · NDC 82983-417 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| C.O. Truxton, Inc.15 mg, 30 mg, 60 mg, 100 mg · NDC 0463-6170, 0463-6160, 0463-6145 +1 | West-ward Pharmaceutical CorpMakes it, tests it and packages it | Location not on file | Not inspected on record |
| Cameron Pharmaceuticals65 mg per 1 mL, 130 mg per 1 mL · NDC 42494-442, 42494-416, 42494-441 +1 | Vitae Enim Vitae Scientific, Inc.Makes it | San Diego, CA, United States | Problems found, fixed voluntarilyJan 2025 |
| Chartwell RX, LLC.15 mg, 16.2 mg, 20 mg per 5 mL, 30 mg, 32.4 mg, 60 mg · NDC 62135-412, 62135-519, 62135-409 +14 | Chartwell Pharmaceuticals Carmel, LLC.Makes it | Carmel, NY, United States | Problems found, fixed voluntarilyOct 2022 |
| Genus Lifesciences Inc.15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg · NDC 64950-578, 64950-571, 64950-572 +5 | Genus Lifesciences Inc.Makes it, tests it, packages it and labels it | Allentown, PA, United States | No problems foundJul 2024 |
| Hikma Pharmaceuticals USA Inc.65 mg per 1 mL, 130 mg per 1 mL · NDC 0641-0477, 0641-0476 | Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Pharmaceutical Associates, Inc.20 mg per 5 mL, 30 mg per 7.5 mL, 60 mg per 15 mL · NDC 0121-0942, 0121-1884, 0121-2826 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, tests it and labels it | Greenville, SC, United States | No problems foundAug 2025 |
| Quagen Pharmaceuticals LLC15 mg, 16.2 mg, 20 mg per 5 mL, 30 mg, 32.4 mg, 60 mg · NDC 70752-168, 70752-165, 70752-161 +6 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Rising Pharma Holdings, Inc.15 mg, 16.2 mg, 20 mg per 5 mL, 30 mg, 32.4 mg, 60 mg · NDC 16571-669, 16571-670, 16571-671 +6 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Strides Pharma Science Limited20 mg per 5 mL · NDC 64380-166 | Strides Pharma, IncMakes it, tests it and packages it | Chestnut Ridge, NY, United States | Problems found, fixed voluntarilyFeb 2022 |
| Winder Laboratories, LLC15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg · NDC 75826-143, 75826-136, 75826-137 +5 | Winder Laboratories, LLCMakes it | Winder, GA, United States | Serious problems, FDA actionAug 2025 |
| BioRamo, LLC20 mg per 5 mL · NDC 54932-207, 54932-501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.20 mg per 5 mL · NDC 68999-962 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ECI Pharmaceuticals LLC100 mg · NDC 51293-694 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.15 mg, 30 mg, 60 mg, 100 mg · NDC 0143-1458, 0143-1495, 0143-1500 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kesin Pharma Corporation20 mg per 5 mL · NDC 81033-163, 81033-164 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Laser Pharmaceuticals, LLC20 mg per 5 mL · NDC 16477-720 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.65 mg per 1 mL, 130 mg per 1 mL · NDC 14789-128, 14789-127 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trigen Laboratories, LLC15 mg, 16.2 mg, 20 mg per 5 mL, 30 mg, 32.4 mg, 60 mg · NDC 13811-303, 13811-300, 13811-304 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Westminster Pharmaceuticals, LLC15 mg, 16.2 mg, 20 mg per 5 mL, 30 mg, 32.4 mg, 60 mg · NDC 69367-694, 69367-445, 69367-691 +15 | The label doesn't name the factory. Plants this company names for other drugs | ||
| e5 Pharma, LLC15 mg, 30 mg, 60 mg, 100 mg · NDC 13517-694, 13517-691, 13517-692 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Phenobarbital 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:
60687-671 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-057 - Atlantic Biologicals Corps.:
17856-0016,17856-0502,17856-0678,17856-1508 - Bryant Ranch Prepack:
72162-1330,71335-2727,63629-1997,71335-2993+18 - Clinical Solutions Wholesale:
58118-0572,58118-0573,58118-1626,58118-0626+2 - Coupler Enterprises Inc.:
67046-950,67046-953 - Coupler LLC:
67046-0059,67046-1434,67046-0780,67046-1543 - Direct Rx:
61919-109 - Lohxa:
70166-536,70166-537 - Major Pharmaceuticals:
0904-6575 - McKesson Packaging Services Business Unit of McKesson Corporation:
63739-192,63739-294 - PD-Rx Pharmaceuticals, Inc.:
43063-953 - Proficient Rx LP:
71205-851,82804-999,71205-845,82804-996+17 - RedPharm Drug. Inc.:
67296-1427,67296-2145 - Remedyrepack Inc.:
70518-4719,70518-4718,70518-4129,70518-4717+2
Recalls
- Mar 14, 2022 · Class II · Vitae Enim Vitae Scientific, Inc. · 2 recall notices
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. - Mar 25, 2019 · Class II · Lohxa LLC
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. - Apr 20, 2017 · Class I · C. O. Truxton
Labeling: Label Mixup; potentially mislabeled - Apr 20, 2017 · Class I · C. O. Truxton
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets - Apr 20, 2017 · Class II · C. O. Truxton · 2 recall notices
Labeling: Label Mixup; potentially mislabeled - Oct 3, 2016 · Class II · West-Ward Pharmaceuticals Corp.
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.