Opioid Agonist
Where is Acetaminophen and Codeine made?
13 companies sell it under their own name and 32 repackagers rebottle it. Their labels name 8 factories in the United States.
United States 8
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| SpecGx LLC15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 0406-0483, 0406-0484, 0406-0485 | 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 | |
| Akorn12 mg per 5 mL / 120 mg per 5 mL, 24 mg per 10 mL / 240 mg per 10 mL, 30 mg per 12.5 mL / 300 mg per 12.5 mL, 36 mg per 15 mL / 360 mg per 15 mL · NDC 50383-079, 50383-337, 50383-338 +2 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Aurolife Pharma LLC15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 13107-058, 13107-059, 13107-060 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Elite Laboratories, Inc.15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 64850-641, 64850-642, 64850-643 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Eywa Pharma Inc15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 71930-054, 71930-055, 71930-056 | 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.30 mg / 300 mg, 60 mg / 300 mg · NDC 52959-003, 52959-446 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Strides Pharma Science Limited15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 64380-448, 64380-446, 64380-447 | Strides Pharma, IncMakes it, tests it and packages it | Chestnut Ridge, NY, United States | Problems found, fixed voluntarilyFeb 2022 |
| Amneal Pharmaceuticals30 mg / 300 mg · NDC 65162-033 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Genus Lifesciences Inc.12 mg per 5 mL / 120 mg per 5 mL · NDC 64950-374 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mutual Pharmaceutical Company, Inc.15 mg / 300 mg, 30 mg / 300 mg, 60 mg / 300 mg · NDC 53489-159, 53489-160, 53489-161 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PharmPak, Inc.30 mg / 300 mg · NDC 54348-015 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.12 mg per 5 mL / 120 mg per 5 mL, 30 mg per 12.5 mL / 300 mg per 12.5 mL · NDC 0121-0504, 0121-1008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Rebel Distributors Corp..30 mg / 300 mg · NDC 21695-242 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acetaminophen and Codeine 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:
50090-0006,50090-5201,50090-4611,50090-4610+2 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0527,80425-0529,80425-0528,80425-0530 - Aidarex Pharmaceuticals LLC:
33261-470,53217-213,33261-001,53217-370+1 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-001,67544-882,67544-002,67544-474+1 - Apotheca, Inc.:
12634-975,12634-526 - Asclemed USA, Inc.:
76420-103,76420-821 - Atlantic Biologicals Corps.:
17856-0079 - Blenheim Pharmacal, Inc.:
10544-032,10544-100 - Bryant Ranch Prepack:
71335-0256,71335-1522,63629-5666,71335-2916+9 - Clinical Solutions Wholesale:
58118-4484,58118-0485 - Coupler Enterprises Inc.:
67046-901,67046-902,67046-908,67046-903+1 - Coupler LLC:
67046-0886 - Direct Rx:
61919-328,61919-484,61919-053,61919-023+4 - Dispensing Solutions Inc.:
55045-1580,66336-059 - EPM Packaging Inc:
61502-903 - Keltman Pharmaceuticals Inc.:
68387-250 - Liberty Pharmaceuticals, Inc.:
0440-7026,0440-7027 - Medsource Pharmaceuticals:
45865-439,45865-466 - NuCare Pharmaceuticals.Inc.:
66267-997,68071-4475,68071-4673,68071-5010+7 - Physicians Total Care, Inc.:
54868-0378,54868-2130,54868-0072,54868-0860 - Preferred Pharmaceuticals, Inc..:
68788-7835,68788-8882,68788-8881,68788-7859 - Proficient Rx LP:
63187-491,63187-815,63187-106,82804-181+1 - RPK Pharmaceuticals, Inc.:
53002-3410,53002-0101,53002-0102 - Rebel Distributors Corp..:
21695-547,42254-022,21695-243,42254-145 - RedPharm Drug Inc.:
67296-0651,67296-0041,67296-0544 - RedPharm Drug. Inc.:
67296-0525,67296-0065,67296-1516,67296-1772+1 - Remedyrepack Inc.:
70518-3705,70518-4104,70518-2628,70518-2764 - RxChange Co.:
33358-001,33358-002 - St. Mary's Medical Park Pharmacy:
60760-938,60760-581 - Stat Rx USA:
16590-361,16590-023 - Unit Dose Services:
50436-3227 - Unit Dose Solutions, Inc.:
87441-009
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc. · 3 recall notices
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Apr 24, 2018 · Class II · Prescript Pharmaceuticals, Inc.
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.