Opioid Antagonist
Where is Naloxone made?
23 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 18 factories in the United States, India and Taiwan.
United States 12India 5Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Uswm, LLC Zimhi5 mg per 0.5 mL · NDC 78670-140 | Alliance Medical Products, Inc. (dba Siegfried Irvine)Makes it | Irvine, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 | |
| Noramco, LLCMakes the active ingredient | Wilmington, DE, United States | Problems found, fixed voluntarilyOct 2025 | |
| Phillips Medisize LLCMakes it, packages it and labels it | Menomonie, WI, United States | Problems found, fixed voluntarilyMar 2025 | |
| Baxter Healthcare Corporation0.4 mg per 1 mL, 1 mg per 1 mL · NDC 36000-310, 36000-308, 43066-142 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| UBI Pharma Inc.Makes it | Hukou, Taiwan | Problems found, fixed voluntarilyJun 2023 | |
| Hospira, Inc.0.4 mg per 1 mL · NDC 0409-1782, 0409-1215, 0409-1219 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Akorn0.4 mg per 1 mL · NDC 17478-041, 17478-042 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| AuroMedics Pharma LLC0.4 mg per 1 mL, 1 mg per 1 mL · NDC 55150-328, 55150-327, 55150-345 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BPI Labs, LLC1 mg per 1 mL · NDC 54288-124 | BPI Labs LLCMakes it and tests it | Largo, FL, United States | Problems found, fixed voluntarilyApr 2025 |
| Dr. Reddy's Laboratories Inc.1 mg per 1 mL · NDC 43598-750 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Fresenius Kabi, LLC0.4 mg per 1 mL, 1 mg per 1 mL · NDC 76045-114, 76045-112 | Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 |
| Hikma Pharmaceuticals USA Inc.0.4 mg per 1 mL, 1 mg per 1 mL · NDC 0641-6132, 0641-6260, 0641-6193 +1 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Hikma Specialty USA Inc. Kloxxado8 mg per 0.1 mL · NDC 59467-679 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| International Medication Systems, Ltd. Rextovy1 mg per 1 mL, 4 mg per 0.25 mL · NDC 76329-3469, 76329-1469, 76329-3369 +1 | International Medication Systems, Ltd.Makes it, tests it, packages it and labels it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Lifestar Pharma LLC.0.4 mg per 1 mL · NDC 70756-658, 70756-850 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Northstar Rx LLC.0.4 mg per 1 mL · NDC 72603-590 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Scienture LLC Rezenopy10 mg per 0.11 mL · NDC 83245-003 | Summit Biosciences Inc.Makes it, tests it, packages it and labels it | Lexington, KY, United States | Problems found, fixed voluntarilyFeb 2025 |
| Somerset Therapeutics, LLC0.4 mg per 1 mL · NDC 70069-071, 70069-072 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Civica, Inc.0.4 mg per 1 mL · NDC 72572-450 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.1 mg per 1 mL · NDC 42023-224 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Emergent Devices Inc. Narcan4 mg per 0.1 mL · NDC 69547-353 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Kaleo, Inc. Naloxone Hydrochloride Injection, USP, Auto-Injector10 mg per 0.4 mL · NDC 60842-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC0.4 mg per 1 mL, 1 mg per 1 mL · NDC 67457-292, 67457-299, 67457-992 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.4 mg per 0.1 mL · NDC 0781-7176 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Summit Biosciences Inc Rezenopy10 mg per 0.11 mL · NDC 43674-004 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ZMI Pharma Inc. Zimhi5 mg per 0.5 mL · NDC 84571-140 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Naloxone 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:
50090-6491,50090-5427,50090-6710,50090-2422+1 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1238,51662-1242,51662-1544,51662-1385+10 - Henry Schein, Inc.:
0404-9920,0404-9773,0404-9922 - Medical Purchasing Solutions, LLC.:
71872-7297,71872-7009,71872-7219,71872-7215+5 - Physicians Total Care, Inc.:
54868-2062,54868-6259 - ProPharma Distribution:
84549-071,84549-072 - Proficient Rx LP:
71205-528,71205-707 - RedPharm Drug. Inc.:
67296-2050,67296-1587 - Remedyrepack Inc.:
70518-4785,70518-2725 - Sina Health Inc:
70385-2013,70385-2033 - TYA Pharmaceuticals:
64725-1782
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jun 4, 2018 · Class I · Hospira Inc, Lake Forest
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.