alpha-1 Adrenergic Agonist
Where is Phenylephrine made?
36 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 23 factories in India, the United States, Canada, Switzerland and China.
India 13United States 4Canada 2Switzerland 2China 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals LLC10 mg per 1 mL · NDC 70121-1578, 70121-1579, 70121-1577 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Mehsana, India | Not inspected on record | |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 | |
| Dr. Reddy's Laboratories Inc. Biorphen, phenylephrine hydrochloride injection, solution0.1 mg per 1 mL, 10 mg per 1 mL, 25 mg per 1 mL, 80 ug per 1 mL, 100 mg per 1 mL · NDC 43598-172, 43598-199, 75907-130 +3 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Sintetica S.a.Makes it, tests it, packages it and labels it | Mendrisio, Switzerland | Problems found, fixed voluntarilyNov 2023 | |
| Sintetica SaMakes it and tests it | Couvet, Switzerland | No problems foundMay 2023 | |
| Gland Pharma Limited10 mg per 1 mL, 25 mg per 1 mL, 100 mg per 1 mL · NDC 68083-338, 68083-339, 68083-465 +3 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Somerset Therapeutics, LLC0.1 mg per 1 mL, 10 mg per 1 mL, 50 mg per 5 mL, 100 mg per 10 mL · NDC 70069-591, 70069-801, 70069-811 +4 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 | |
| Alcon Laboratories, Inc. Phenylephrine Hydrochloride25 mg per 1 mL, 100 mg per 1 mL · NDC 0065-0343, 0065-0349 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Armas Pharmaceuticals Inc.10 mg per 1 mL, 50 mg per 5 mL, 100 mg per 10 mL · NDC 72485-504, 72485-506, 72485-505 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| AuroMedics Pharma LLC10 mg per 1 mL · NDC 55150-301, 55150-302, 55150-300 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BE Pharmaceuticals Inc.10 mg per 1 mL · NDC 71839-127, 71839-128, 71839-129 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Bausch & Lomb Americas Inc.25 mg per 1 mL · NDC 82260-102, 82260-103 | Jubilant HollisterStier General PartnershipMakes it | Kirkland, Canada | Serious problems, FDA actionNov 2025 |
| Baxter Healthcare Corporation10 mg per 1 mL · NDC 36000-358, 36000-360, 36000-362 | Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 |
| Camber Pharmaceuticals Inc.10 mg per 1 mL · NDC 31722-343, 31722-344, 31722-345 | Aspiro Pharma LimitedMakes it | Siddipet, India | Problems found, fixed voluntarilyAug 2023 |
| Caplin Steriles Limited10 mg per 1 mL, 25 mg per 1 mL, 50 mg per 5 mL, 100 mg per 1 mL, 100 mg per 10 mL · NDC 65145-115, 65145-150, 65145-117 +3 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Eton Pharmaceuticals, Inc. Biorphen0.1 mg per 1 mL, 10 mg per 1 mL · NDC 71863-208, 71863-202, 71863-203 | Sintetica S.a.Makes it, tests it, packages it and labels it | Mendrisio, Switzerland | Problems found, fixed voluntarilyNov 2023 |
| First Nation Group, LLC25 mg per 1 mL, 100 mg per 1 mL · NDC 81469-169, 81469-168 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Fresenius Kabi USA, LLC10 mg per 1 mL · NDC 65219-388 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Fresenius Kabi, LLC10 mg per 1 mL · NDC 63323-751 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hainan Poly Pharm. Co., Ltd.10 mg per 1 mL · NDC 14335-440, 14335-441, 14335-442 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg per 1 mL · NDC 23155-620 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc. Phenylephrine Hydrochloride, Immphentiv10 mg per 1 mL, 100 ug per 1 mL · NDC 0641-6229, 0641-6142, 0641-6188 +3 | Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Hospira, Inc.10 mg per 1 mL · NDC 0409-1800 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Leading Pharma, LLC25 mg per 1 mL, 100 mg per 1 mL · NDC 69315-324, 69315-323 | Caplin Steriles LimitedMakes it | Gummidipoondi, India | No problems foundAug 2024 |
| Lifestar Pharma LLC.10 mg per 1 mL, 25 mg per 1 mL, 50 mg per 5 mL, 100 mg per 1 mL, 100 mg per 10 mL · NDC 70756-621, 70756-614, 70756-623 +4 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Meitheal Pharmaceuticals Inc.10 mg per 1 mL · NDC 71288-808, 71288-807 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Northstar Rx LLC.25 mg per 1 mL, 100 mg per 1 mL · NDC 72603-530, 72603-520 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Novadoz Pharmaceuticals LLC10 mg per 1 mL · NDC 72205-264, 72205-265, 72205-266 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Paragon BioTeck, Inc. Phenylephrine Hydrochloride25 mg per 1 mL, 100 mg per 1 mL · NDC 42702-103, 42702-102 | Jubilant HollisterStier General PartnershipMakes it | Kirkland, Canada | Serious problems, FDA actionNov 2025 |
| Sandoz Inc.10 mg per 1 mL · NDC 0781-9226, 0781-9227, 0781-9228 +3 | Delpharm Boucherville Canada Inc.Makes it, tests it, packages it, labels it and sterilizes it | Boucherville, Canada | Problems found, fixed voluntarilyJan 2024 |
| Allergan, Inc.1.2 mg per 1 mL · NDC 0023-0000 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cantrell Drug Company40 ug per 1 mL, 160 ug per 1 mL, 300 ug per 1 mL · NDC 52533-110, 52533-130, 52533-147 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc. Phenylephrine Hydrochloride10 mg per 1 mL · NDC 72572-570, 72572-571 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.10 mg per 1 mL · NDC 42023-214, 42023-215 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.10 mg per 1 mL · NDC 58657-851, 58657-852, 58657-853 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Provepharm Inc.10 mg per 1 mL · NDC 81284-211, 81284-212, 81284-213 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC25 mg per 1 mL, 100 mg per 1 mL · NDC 70512-866, 70512-865 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL · NDC 25021-315 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xellia Pharmaceuticals USA LLC10 mg per 1 mL, 50 mg per 5 mL, 100 mg per 10 mL · NDC 70594-063, 70594-065, 70594-064 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Phenylephrine 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:
50090-4514 - Cardinal Health 107, LLC:
55154-8226 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1249,51662-1576 - Henry Schein, Inc.:
0404-9931 - Medical Purchasing Solutions, LLC.:
71872-7267,71872-7273,71872-7231,71872-7159+4 - ProPharma Distribution:
84549-621
Recalls
- Mar 11, 2021 · Class II · Sagent Pharmaceuticals Inc
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.