Barbiturate, Central Nervous System Stimulant
Where is Acetaminophen and Butalbital and Caffeine made?
24 companies sell it under their own name and 31 repackagers rebottle it. Their labels name 9 factories in the United States and Israel.
United States 8Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Quagen Pharmaceuticals LLC40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 70752-144, 70752-142, 70752-141 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 | |
| Aurolife Pharma LLC40 mg / 50 mg / 325 mg · NDC 13107-075 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Caraco Pharmaceutical Laboratories, Ltd.40 mg / 50 mg / 300 mg · NDC 51672-4222 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Granules Pharmaceuticals Inc.40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 70010-044, 70010-149 | Granules Pharmaceuticals Inc.Makes it, tests it and labels it | Chantilly, VA, United States | Problems found, fixed voluntarilyApr 2026 |
| KVK-TECH, Inc.40 mg / 50 mg / 325 mg · NDC 10702-253 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| LGM Pharma Solutions, LLC40 mg / 50 mg / 325 mg · NDC 79739-7320 | LGM Pharma Solutions, LLCMakes it, tests it, packages it and labels it | Irvine, CA, United States | No problems foundJan 2025 |
| Lannett Company, Inc.40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 0527-4095, 0527-4094, 0527-1695 | Lannett Company, LLCMakes it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Nexgen Pharma, Inc.40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 0722-7029, 0722-7320 | Nexgen Pharma, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Sunrise Pharmaceutical, Inc.40 mg / 50 mg / 300 mg · NDC 11534-187 | Sunrise Pharmaceutical IncMakes it, packages it and labels it | Rahway, NJ, United States | Problems found, fixed voluntarilyMar 2026 |
| Xspire Pharma, Llc40 mg / 50 mg / 300 mg · NDC 42195-955 | Xspire PharmaMakes it | Location not on file | Not inspected on record |
| Zydus Pharmaceuticals (USA) Inc.40 mg / 50 mg / 325 mg · NDC 70710-1378 | Nesher Pharmaceuticals (USA) LLCMakes it and tests it | Location not on file | Not inspected on record |
| Actavis Pharma, Inc.40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 52544-080, 0591-2640, 0591-3369 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amici Pharma Inc.40 mg / 50 mg / 325 mg · NDC 69292-305 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Atley Pharmaceuticals, Inc.40 mg / 50 mg / 300 mg · NDC 59702-661 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.40 mg / 50 mg / 325 mg · NDC 62135-751 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.40 mg / 50 mg / 325 mg · NDC 75907-009 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Genus Lifesciences Inc.40 mg per 15 mL / 50 mg per 15 mL / 325 mg per 15 mL · NDC 64950-290 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.40 mg / 50 mg / 500 mg · NDC 0143-0170 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.40 mg / 50 mg / 300 mg · NDC 10135-628 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mikart, LLC40 mg / 50 mg / 325 mg · NDC 46672-053 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Seton Pharmaceuticals, LLC40 mg / 50 mg / 300 mg, 40 mg / 50 mg / 325 mg · NDC 13925-535, 13925-536 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC40 mg / 50 mg / 300 mg · NDC 43547-686 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Strides Pharma Science Limited40 mg / 50 mg / 325 mg · NDC 64380-157 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Westminster Pharmaceuticals, LLC40 mg / 50 mg / 325 mg · NDC 69367-203 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acetaminophen and Butalbital and Caffeine 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:
50090-0371,50090-2105,50090-2564,50090-7042+1 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0215,80425-0497,80425-0567,80425-0570 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-394,71610-042 - Asclemed USA, Inc.:
76420-802 - Atlantic Biologicals Corps.:
17856-1787 - AvKARE, Inc.:
42291-181 - AvPAK:
50268-553 - Bryant Ranch Prepack:
72162-1232,63629-2372,71335-0365,63629-2087+11 - Cardinal Health 107, LLC:
55154-3356 - Carilion Materials Management:
68151-1313 - Direct Rx:
61919-022,72189-441,72189-600 - Golden State Medical Supply, Inc.:
51407-556 - H.J. Harkins Co., Inc.:
52959-913 - Hawaii Repack, Inc.:
85534-0046 - Keltman Pharmaceuticals Inc.:
68387-520 - Major Pharmaceuticals:
0904-6938 - Medsource Pharmaceuticals:
45865-352 - Northwind Pharmaceuticals:
51655-590 - NuCare Pharmaceuticals.Inc.:
68071-2365,68071-2927,68071-3249 - Physicians Total Care, Inc.:
54868-1036 - Preferred Pharmaceuticals, Inc..:
68788-9025,68788-9711,68788-6939,68788-9287+3 - Proficient Rx LP:
63187-520,63187-933,71205-981,71205-510 - RPK Pharmaceuticals, Inc.:
53002-6030 - Rebel Distributors Corp..:
21695-209,21695-257,42254-323,21695-843 - RedPharm Drug Inc.:
67296-0718 - RedPharm Drug. Inc.:
67296-2204 - Remedyrepack Inc.:
70518-1134,70518-4309,70518-4601 - RxChange Co.:
33358-059 - St. Mary's Medical Park Pharmacy:
60760-865 - Stat Rx USA:
16590-022,42549-553,16590-581 - Unit Dose Services:
50436-4856,50436-3369,50436-1695
Recalls
- Sep 28, 2021 · Class III · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · 2 recall notices
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.