Opioid Antagonist
Where is Naltrexone made?
11 companies sell it under their own name and 16 repackagers rebottle it. Their labels name 7 factories in the United States and India.
United States 5India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.50 mg · NDC 16729-081 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Alkermes, Inc. Vivitrol380 mg per 4 mL · NDC 65757-300, 65757-301 | Alkermes, IncMakes it | Wilmington, OH, United States | Problems found, fixed voluntarilyOct 2023 |
| Amneal Pharmaceuticals380 mg per 5 mL · NDC 69238-2794 | Alkermes, IncMakes it | Wilmington, OH, United States | Problems found, fixed voluntarilyOct 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.50 mg · NDC 47335-326 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Elite Laboratories, Inc.50 mg · NDC 64850-300 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| H.J. Harkins Co., Inc.50 mg · NDC 76519-1160 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50 mg · NDC 23155-886 | Chartwell Pharmaceuticals Congers, LLC.Makes it, tests it, packages it and labels it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Precision Dose Inc.50 mg · NDC 68094-909 | Elite Laboratories, Inc.Makes it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| SpecGx LLC50 mg · NDC 0406-1170 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| TAGI Pharma, Inc.50 mg · NDC 51224-206 | Elite Laboratories, Inc.Makes it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Chartwell RX, LLC.50 mg · NDC 62135-242 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Naltrexone 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:
50090-2866,50090-3076,50090-4925,50090-6820+1 - Aidarex Pharmaceuticals LLC:
53217-261 - American Health Packaging:
68084-291 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-919,71610-964,53401-008,53401-023 - AvKARE, Inc.:
42291-632 - Bryant Ranch Prepack:
72162-1566,72162-2154,71335-1480,71335-2481+14 - Coupler LLC:
67046-0306,67046-0060 - Golden State Medical Supply, Inc.:
51407-959 - Major Pharmaceuticals:
0904-7036 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8579 - NuCare Pharmaceuticals.Inc.:
68071-2721,68071-3654 - Physicians Total Care, Inc.:
54868-5574 - Precision Dose Inc.:
68094-853 - Proficient Rx LP:
82804-199 - RedPharm Drug. Inc.:
67296-2282 - Remedyrepack Inc.:
70518-1146,70518-2718,70518-4344
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Sep 26, 2019 · Class II · Alkermes, Inc.
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted. - Aug 8, 2019 · Class II · Alkermes Inc
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted. - Mar 4, 2014 · Class II · Alkermes, Inc.
Customer complaints for failure to deliver the dose. - Nov 6, 2012 · Class II · Alkermes, Inc.
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.