Sterile Water
Water · Injection · Intravenous, Intramuscular, Subcutaneous
Current shortage
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release September 2026. Check wholesalers for inventory.
Sterile Water, Injection, 1 mL/1 mL (NDC 0487-6105-01) – Limited Availability (Nephron Pharmaceuticals Corporation, updated Aug 4, 2026)
Small amount of inventory available with 12/31/2026 dating
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-04) – Limited Availability (Baxter Healthcare, updated Sep 17, 2026)
Estimated recovery: September 2026
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesalers for inventory
Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00) – Available (B. Braun Medical Inc., updated Sep 22, 2026)
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-50) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10) – Available (B. Braun Medical Inc., updated Sep 22, 2026)
Sterile Water, Injection, 1 mL/1 mL (NDC 0641-6147-10) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be scheduled for manufacturing. Product will be made available as it is released.
Uses
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage and administration
The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications
Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Warnings
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Precautions
Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy : Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.
Side effects
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Drug interactions
Drug Interactions Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.
Pediatric use
Pediatric Use Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Overdosage
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re‑evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .
Description
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For I.V. injection, add sufficient solute to make an approximately isotonic solution. Water for Injection, USP is chemically designated H 2 O. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.
How supplied
Sterile Water for Injection, USP is a sterile, clear, and colorless water for injection, available as a single dose vial, and is supplied in the following: Unit of Sale Total Content NDC 0409-0024-10 Tray of 25 Single-dose Plastic Fliptop Vials 10 mL Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1605-1.0 Revised: 3/2025 sterile water-01
Label text from the FDA structured product label by Hospira, Inc. (revised May 7, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Water in 43 products
Sterile Water NDC products (43)
Sterile Water recalls
- D-0495-2026 Apr 29, 2026 · Class II · Ongoing
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - D-0296-2026 Feb 4, 2026 · Class II · Ongoing
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution - D-0652-2025 Sep 24, 2025 · Class II · Ongoing
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. - D-0364-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: Potential product carryover. - D-0178-2023 Feb 1, 2023 · Class II · Terminated
CGMP Deviations: potential for trace amounts of product carryover. - D-1031-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-0384-2021 May 26, 2021 · Class II · Terminated
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Frequently asked questions
What is Sterile Water used for?
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
What are the side effects of Sterile Water?
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient,… See the full label for the complete list.
Who makes Sterile Water?
Sterile Water is listed by 22 labelers in the FDA NDC directory, including Becton Dickinson and Company, Cardinal Health 107, LLC, Chartwell RX, LLC, Civica, Inc..
Has Sterile Water been recalled?
The FDA enforcement database lists 7 recalls for Sterile Water, most recently D-0495-2026 (class ii): Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.