Opioid Agonist
Where is Acetaminophen and Hydrocodone made?
24 companies sell it under their own name and 31 repackagers rebottle it. Their labels name 16 factories in the United States.
United States 16
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Golden State Medical Supply, Inc.5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 60429-592, 60429-591, 60429-590 | SpecGx LLCMakes it | Hobart, NY, United States | No problems foundMar 2020 |
| SpecGx LLCMakes the active ingredient | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| SpecGx LLCMakes the active ingredient | Greenville, IL, United States | Problems found, fixed voluntarilyFeb 2026 | |
| SpecGx LLC5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 0406-0378, 0406-0125, 0406-0377 +3 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| SpecGx LLCMakes the active ingredient | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| SpecGx LLCMakes the active ingredient | Greenville, IL, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Genus Lifesciences Inc.325 mg per 15 mL / 7.5 mg per 15 mL · NDC 64950-373, 64950-343 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, packages it and labels it | Greenville, SC, United States | No problems foundAug 2025 |
| TriRx Huntsville Pharmaceutical Services, LLCMakes it, packages it and labels it | Huntsville, AL, United States | No problems foundAug 2023 | |
| Aurolife Pharma LLC5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 13107-213, 13107-021, 13107-212 +3 | Aurolife Pharma LLCMakes it, tests it, packages it and labels it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Camber Pharmaceuticals Inc.2.5 mg / 325 mg, 5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 31722-997, 31722-940, 31722-942 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Elite Laboratories, Inc.2.5 mg / 325 mg, 5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 64850-633, 64850-630, 64850-632 +1 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Epic Pharma, LLC5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 42806-113, 42806-112, 42806-111 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Eywa Pharma Inc5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 71930-044, 71930-021, 71930-043 +4 | Wes Pharma IncMakes it, tests it, packages it and labels it | Westminster, MD, United States | Problems found, fixed voluntarilyNov 2025 |
| H.J. Harkins Co., Inc.2.5 mg / 325 mg, 5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 52959-324, 76519-1011, 76519-1079 +3 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| KVK-TECH, Inc.5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 10702-194, 10702-191, 10702-193 +3 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Lupin Pharmaceuticals, Inc.5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 43386-353, 43386-358, 43386-352 +3 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Novel Laboratories, Inc.5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 300 mg / 7.5 mg, 325 mg / 7.5 mg · NDC 40032-353, 40032-358, 40032-352 +3 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Pharmaceutical Associates, Inc.5 mg per 10 mL / 217 mg per 10 mL, 108 mg per 5 mL / 2.5 mg per 5 mL, 325 mg per 15 mL / 7.5 mg per 15 mL · NDC 0121-4772, 0121-2316, 0121-1544 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| Rhodes Pharmaceuticals L.P.5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 42858-203, 42858-202, 42858-201 | Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 |
| Strides Pharma Science Limited5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 64380-442, 64380-441, 64380-440 | Strides Pharma, IncMakes it, tests it and packages it | Chestnut Ridge, NY, United States | Problems found, fixed voluntarilyFeb 2022 |
| Upsher-Smith Laboratories, Inc.5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 0245-0412, 0245-0411, 0245-0410 | Bora Pharmaceuticals Inc.Makes it and packages it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 |
| XLCare Pharmaceuticals, Inc.2.5 mg / 325 mg, 5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 72865-112, 72865-204, 72865-109 +5 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Amneal Pharmaceuticals5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 53746-110, 65162-115, 53746-109 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC5 mg / 300 mg, 5 mg / 325 mg, 10 mg / 300 mg, 10 mg / 325 mg, 10 mg per 15 mL / 300 mg per 15 mL, 300 mg / 7.5 mg · NDC 27808-116, 27808-037, 27808-130 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Granules Pharmaceuticals Inc.5 mg / 325 mg, 10 mg / 325 mg, 325 mg / 7.5 mg · NDC 70010-674, 70010-673, 70010-672 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.10 mg per 15 mL / 300 mg per 15 mL · NDC 0054-0843 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Keltman Pharmaceuticals Inc.5 mg / 325 mg · NDC 68387-236 | The label doesn't name the factory. Plants this company names for other drugs | ||
| McKesson Packaging Services Business Unit of McKesson Corporation5 mg / 500 mg · NDC 63739-455 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PharmPak, Inc.5 mg / 325 mg · NDC 54348-066 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acetaminophen and Hydrocodone 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:
50090-4064,50090-4066,50090-3689,50090-4067+8 - Aidarex Pharmaceuticals LLC:
53217-267,33261-058,53217-192,33261-881+4 - Altura Pharmaceuticals, Inc.:
63874-834,63874-293,63874-861,63874-279+3 - American Health Packaging:
60687-418,60687-407,60687-417,60687-396 - Apotheca, Inc.:
12634-144,12634-978,12634-256,12634-260+2 - Asclemed USA, Inc.:
76420-215,76420-877,87063-051,76420-257+5 - Atlantic Biologicals Corps.:
17856-0450,17856-0640 - AvPAK:
50268-402,50268-400,50268-401 - Bryant Ranch Prepack:
63629-2310,63629-1183,63629-1184,72162-1998+70 - Coupler Enterprises Inc.:
67046-925,67046-928,67046-926,67046-927 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-555 - Direct Rx:
61919-828,61919-156,61919-118,72189-399+13 - Dispensing Solutions Inc.:
66336-444,66336-408,55045-2386,66336-406+7 - EPM Packaging Inc:
61502-908,61502-914,61502-913 - Keltman Pharmaceuticals Inc.:
68387-235,68387-230 - Lake Erie Medical DBA Quality Care Products LLC:
55700-991,55700-992 - Liberty Pharmaceuticals, Inc.:
0440-7605,0440-7610 - Life Line Home Care Services, Inc.:
75921-881 - Medsource Pharmaceuticals:
45865-411,45865-419,45865-605,45865-407+1 - Northwind Pharmaceuticals:
51655-804 - NuCare Pharmaceuticals.Inc.:
68071-2629,68071-2762,68071-4941,66267-319+9 - Physicians Total Care, Inc.:
54868-4034,54868-4974,54868-6407,54868-4237+9 - Preferred Pharmaceuticals, Inc..:
68788-6352 - Proficient Rx LP:
63187-120,63187-778,71205-660,82804-003+5 - Rebel Distributors Corp..:
21695-775,42254-301,21695-272,42254-214+24 - RedPharm Drug Inc.:
67296-0499,67296-0804,67296-0649,67296-0719+8 - RedPharm Drug. Inc.:
67296-1238,67296-1631,67296-1335,67296-1542+21 - St. Mary's Medical Park Pharmacy:
60760-871,60760-872,60760-692,60760-870+1 - Stat Rx USA:
42549-514,16590-118,42549-653,16590-119+16 - TYA Pharmaceuticals:
64725-0026 - Unit Dose Services:
50436-2612,50436-2171,50436-2605,50436-0109+1
Recalls
- Nov 19, 2021 · Class II · Ascent Pharmaceuticals, Inc.
Product Mix-up - May 24, 2018 · Class III · Lupin Somerset
Labeling: Missing Label
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.