Prescription drug
Where is Water made?
25 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 16 factories in the United States, India, China, Germany and Malaysia.
United States 10India 2China 2Germany 1Malaysia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC1 mL per 1 mL, 1000 mL per 1000 mL · NDC 63323-185, 63323-178 | Fresenius Kabi Deutschland GmbHMakes it | Friedberg, Germany | Problems found, fixed voluntarilyDec 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 | |
| Fresenius Kabi USA, LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Baxter Healthcare Corporation Sterile Water100 mL per 100 mL · NDC 0338-0013, 0338-0003, 0338-0004 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Cleveland, MS, United States | Serious problems, FDA actionSep 2025 |
| Baxter Healthcare CorporationMakes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Marion, NC, United States | Serious problems, FDA actionFeb 2024 | |
| Becton Dickinson and Company1 mL per 1 mL, 1000 mL per 1000 mL · NDC 17271-802, 17271-750 | Fresenius Kabi Deutschland GmbHMakes it, makes the active ingredient and tests it | Friedberg, Germany | Problems found, fixed voluntarilyDec 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Fresenius Kabi USA, LLC1 mL per 1 mL · NDC 65219-187, 65219-495, 65219-497 +1 | Fresenius Kabi Deutschland GmbHMakes it, makes the active ingredient and tests it | Friedberg, Germany | Problems found, fixed voluntarilyDec 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 | |
| Hospira, Inc. Sterile Water, Bacteriostatic Water1 mL per 1 mL · NDC 0409-4887, 0409-0024, 0409-3977 +1 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 | |
| American Regent, Inc.1 mL per 1 mL · NDC 0517-3005, 0517-3010, 0517-3020 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Biocon Biologics Inc. INSULIN DILUTING MEDIUM FOR Kirsty1 mL per 1 mL · NDC 83257-006 | Biocon Sdn.bhd.Makes it, tests it and packages it | Iskander Puteri, Malaysia | Problems found, fixed voluntarilySep 2024 |
| Chartwell RX, LLC.1 mL per 1 mL · NDC 62135-833 | Nephron SC, LLCMakes it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| Civica, Inc.1 mL per 1 mL · NDC 72572-747 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Dr. Reddy's Laboratories Inc.1 mL per 1 mL · NDC 43598-126 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Fujian Genohope Biotech Ltd.1 mL per 1 mL · NDC 84502-115 | Fujian Genohope Biotech Ltd.Makes it, tests it and labels it | Putian, China | Problems found, fixed voluntarilyJan 2026 |
| Hikma Pharmaceuticals USA Inc.1 mL per 1 mL · NDC 0641-6147 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| ICU Medical Inc. Sterile Water1 mL per 1 mL, 1000 mL per 1000 mL · NDC 0990-7118, 0990-8139, 0990-6139 +3 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Image Amazon LLC1000 mg per 1 mL · NDC 85380-1001 | Imagine Amazon LLCMakes it | Miami, FL, United States | Not inspected on record |
| Medefil, Inc.100 mL per 100 mL · NDC 64253-020 | Medefil, LLCMakes it | Glendale Heights, IL, United States | Problems found, fixed voluntarilyApr 2025 |
| Meitheal Pharmaceuticals Inc. Insulin Diluting Medium for Garzulys1 mL per 1 mL · NDC 71288-909 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Nephron Pharmaceuticals Corporation1 mL per 1 mL · NDC 0487-6105 | Nephron SC, LLCMakes it, tests it, packages it and labels it | West Columbia, SC, United States | Problems found, fixed voluntarilyAug 2025 |
| B. Braun Medical Inc. Sterile Water1 mL per 1 mL, 100 mL per 100 mL · NDC 0264-7385, 0264-7850, 0264-2101 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Bavarian Nordic A/S Diluent Component0.65 mL per 0.65 mL · NDC 50632-003 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Eli Lilly and Company Sterile Diluent1 mL per 1 mL · NDC 0002-0800 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.1 mL per 1 mL · NDC 0143-9339 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Merck Sharp & Dohme LLC Sterile Diluent0.7 mL per 0.7 mL · NDC 0006-4309, 0006-4175 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novo Nordisk Insulin Diluting Medium for NovoLog1 mL per 1 mL · NDC 0169-2001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.1 mL per 1 mL · NDC 0781-6021 | The label doesn't name the factory. Plants this company names for other drugs | ||
| United Therapeutics Corporation Sterile Diluent for Remodulin1 mL per 1 mL · NDC 66302-150 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Water 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:
50090-2874 - Asclemed USA, Inc.:
76420-082 - Cardinal Health 107, LLC:
55154-9588,55154-0127 - General Injectables & Vaccines, Inc.:
52584-147 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1473,51662-1474,51662-1266,51662-1265+1 - Henry Schein, Inc.:
0404-9970,0404-9971,0404-9959 - Medical Purchasing Solutions, LLC.:
71872-7182,71872-7129,71872-7290 - ProPharma Distribution:
84549-850,84549-887,84549-977 - Remedyrepack Inc.:
70518-4732 - TYA Pharmaceuticals:
64725-4887 - US MedSource, LLC:
61699-3977
Recalls
- Apr 2, 2026 · Class II · B Braun Medical Inc
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - Dec 22, 2025 · Class II · Baxter Healthcare Corporation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution - Aug 26, 2025 · Class II · B Braun Medical Inc
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. - Mar 12, 2024 · Class II · Eli Lilly & Company
CGMP Deviations - Feb 23, 2023 · Class II · Nephron Sc Inc
CGMP Deviations: Potential product carryover. - Jan 12, 2023 · Class II · Nephron Sc Inc
CGMP Deviations: potential for trace amounts of product carryover. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Apr 5, 2022 · Class I · Cardinal Health Inc.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. - May 3, 2021 · Class II · Pfizer Inc.
Presence of Particulate Matter: particulate matter identified as an insect in one vial. - Mar 22, 2021 · Class I · Novo Nordisk Inc · 2 recall notices
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. - Sep 6, 2019 · Class II · Pfizer Inc.
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.