Does Water have a boxed warning?

The label we quote has no boxed warning, but 1 of 48 FDA labels for this medicine do. Check the label of your own product.

Is there a shortage of Water?

The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 29, 2026). Ask your pharmacist about alternatives.

Has Water been recalled?

FDA enforcement reports list 12 recalls of products of this medicine; the newest started April 2, 2026 (Class II). A recall usually concerns specific lots, not every product.

27 companies list prescription products of Water in the FDA NDC Directory, including Fresenius Kabi USA, LLC, HF Acquisition Co LLC, DBA HealthFirst and B. Braun Medical Inc..

Water (Sterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys): uses, warnings, recalls

Quick answers

What is Water used for?: The FDA-approved label (Sterile Water, Remedyrepack Inc., August 24, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Water have a boxed warning?: The label we quote has no boxed warning, but 1 of 48 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Water?: The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 29, 2026). Ask your pharmacist about alternatives.
Has Water been recalled?: FDA enforcement reports list 12 recalls of products of this medicine; the newest started April 2, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Water?: 27 companies list prescription products of Water in the FDA NDC Directory, including Fresenius Kabi USA, LLC, HF Acquisition Co LLC, DBA HealthFirst and B. Braun Medical Inc..

What Water is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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.

— FDA label: Sterile Water, Remedyrepack Inc., effective August 24, 2026. Read the full label on DailyMed →

The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

1 of 48 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Injection · Injection, solution · Irrigant
Route	Intravenous · Subcutaneous · Intramuscular · Irrigation
Prescription products	53 in the FDA NDC Directory
Brand names	Sterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys, Insulin Diluting Medium for Novolog, Diluent, Sterile Diluent for Treprostinil, Sterile Diluent for Remodulin, Insulin Diluting Medium for Kirsty, Sterile Diluent

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Water, by strength and form
Strength and form	Generic or brand	Pharmacies pay
water 100% injection	Generic	$0.3096 per mL
water 100% injection, solution	Generic	$0.2192 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

Fresenius Kabi USA, LLC6 products
HF Acquisition Co LLC, DBA HealthFirst5 products
B. Braun Medical Inc.4 products
Henry Schein, Inc.4 products
Hospira, Inc.3 products
ProPharma Distribution3 products
ICU Medical Inc.3 products
Hikma Pharmaceuticals USA Inc.2 products
Becton Dickinson and Company2 products
Baxter Healthcare Company2 products
Medical Purchasing Solutions, LLC2 products
Cardinal Health 107, LLC2 products
Baxter Healthcare Corporation2 products
A-S Medication Solutions1 product
Medefil, Inc.1 product
Remedyrepack Inc.1 product
Meitheal Pharmaceuticals Inc.1 product
Novo Nordisk1 product
Nephron Pharmaceuticals Corporation1 product
Sandoz Inc1 product
Dr. Reddy's Laboratories Inc.1 product
United Therapeutics Corporation1 product
Asclemed USA, Inc.1 product
Biocon Biologics Inc.1 product
Chartwell RX, LLC1 product
Civica, Inc.1 product
Eli Lilly and Company1 product

FDA approval history

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.
BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
BLA020563 HUMALOG, HUMALOG KWIKPEN, HUMALOG PEN, HUMALOG TEMPO PEN	Lilly	June 14, 1996	84, latest May 7, 2025 2025: Labeling · 2023: Labeling · 2019: Labeling
BLA020986 NOVOLOG, NOVOLOG FLEXPEN, NOVOLOG FLEXTOUCH, NOVOLOG INNOLET, NOVOLOG PENFILL	Novo Nordisk Inc	June 7, 2000	52, latest February 28, 2023 2023: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling
BLA761188 KIRSTY	Biocon Biologics Inc	July 15, 2025	—
BLA761497 GARZULYS	Emerge Bioscience Pte. Ltd.	July 24, 2026	—
NDA016734 STERILE WATER IN PLASTIC CONTAINER	B Braun	September 10, 1970	42, latest March 30, 2015 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC)
NDA017428 STERILE WATER	Baxter Hlthcare	December 31, 1974	55, latest October 17, 2017 2017: Labeling · 2016: Manufacturing (CMC) · 2011: Manufacturing (CMC)
NDA017866 STERILE WATER IN PLASTIC CONTAINER	Baxter Hlthcare	May 30, 1980	40, latest October 17, 2017 2017: Labeling · 2014: Manufacturing (CMC) · 2001: Manufacturing (CMC)
NDA018233 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	Otsuka Icu Medcl	February 18, 1980	55, latest September 5, 2013 2013: Manufacturing (CMC) · 2007: Manufacturing (CMC) · 2005: Labeling
NDA018313 STERILE WATER IN PLASTIC CONTAINER	Otsuka Icu Medcl	February 22, 1980	40, latest April 9, 2004 2004: Labeling · 1997: Manufacturing (CMC) · 1997: Manufacturing (CMC)
NDA018632 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	Baxter Hlthcare	June 30, 1982	35, latest May 26, 2016 2016: Labeling · 2014: Manufacturing (CMC) · 2006: Labeling
NDA018801 STERILE WATER FOR INJECTION	Hospira	October 27, 1982	25, latest December 21, 2016 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC)
NDA018802 BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	Hospira	October 27, 1982	14, latest December 22, 2016 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC)
NDA019633 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	B Braun	February 29, 1988	17, latest August 29, 2014 2014: Manufacturing (CMC) · 2003: Labeling · 2002: Manufacturing (CMC)
NDA019869 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	Otsuka Icu Medcl	December 26, 1989	9, latest May 20, 2003 2003: Labeling · 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC)
NDA021272 REMODULIN	United Therap	May 21, 2002	15, latest March 7, 2023 2023: Labeling · 2021: Manufacturing (CMC) · 2018: Labeling

Generic approvals (9)

ANDA088400Fresenius Kabi USA · January 16, 1984
ANDA206369Hikma · September 2, 2015
ANDA209689Fresenius Kabi USA · November 24, 2017
ANDA203649Sandoz · November 30, 2017
ANDA211188Medefil Inc · December 2, 2019
ANDA210214DR Reddys · May 22, 2020
ANDA211222Nephron · February 10, 2021
ANDA212735Hikma · January 31, 2023
ANDA216123Fresenius Kabi USA · August 12, 2024

Shortage status

Current shortage · updated October 29, 2026 · first posted November 23, 2021

Product	Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20)
Availability	Available
Company	Hospira, Inc., a Pfizer Company

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

April 2, 2026 · Class II · Ongoing · D-0495-2026

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60. — B BRAUN MEDICAL INC
December 22, 2025 · Class II · Ongoing · D-0296-2026

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Baxter Healthcare Corporation
August 26, 2025 · Class II · Ongoing · D-0652-2025

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. — B BRAUN MEDICAL INC
March 12, 2024 · Class II · Completed · D-0445-2024

CGMP Deviations

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, I — Eli Lilly & Company
February 23, 2023 · Class II · Terminated · D-0364-2023

CGMP Deviations: Potential product carryover.

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01 — Nephron Sc Inc
January 12, 2023 · Class II · Terminated · D-0178-2023

CGMP Deviations: potential for trace amounts of product carryover.

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbi — Nephron Sc Inc
April 13, 2022 · Class II · Terminated · D-1031-2022

cGMP deviations: Temperature abuse

Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06 — Mckesson Medical-Surgical Inc. Corporate Office
April 5, 2022 · Class I · Completed · D-0882-2022

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59 — Cardinal Health Inc.
May 3, 2021 · Class II · Terminated · D-0384-2021

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25 — Pfizer Inc.
March 22, 2021 · Class I · Terminated · D-0615-2021

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.

NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit) — Novo Nordisk Inc
March 22, 2021 · Class I · Terminated · D-0616-2021

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.

NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90 — Novo Nordisk Inc
September 6, 2019 · Class II · Terminated · D-1852-2019

Lack of Assurance of Sterility

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 — Pfizer Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)	150985, 242120, 311040, 349407, 349408, 349409, 349410, 351926, 352211, 352212 … (+10)
SPL set ID of the quoted label	5dd5d148-6e23-41de-bff5-551b2aea9598
FDA labels (SPL)	48
FDA applications	BLA020563, BLA020986, BLA761188, BLA761497, NDA016734, NDA017428, NDA017866, NDA018233, NDA018313, NDA018632, NDA018801, NDA018802, NDA019633, NDA019869, NDA021272, 9 ANDA
Active ingredients (FDA)	WATER

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Sterile Water, Remedyrepack Inc., effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers

Water

Official FDA data, not advice

At a glance