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Sterile Water Injection shortage

Sterile Water Injection is currently listed in shortage by the FDA. The FDA lists 12 affected products. The reported reason: Demand increase for the drug; Other. This page was last refreshed from FDA data on Oct 3, 2026.

Current ⚠ Supply risk: Low Other 12 products 5 manufacturers 1,775 days · 4.9 yr First posted Nov 23, 2021 Updated Sep 22, 2026
Here’s the bottom line

Sterile Water Injection has been in shortage for over a year due to high demand. Some makers still report available supply, and the same product is also listed by makers that have not reported a shortage, including B. Braun Medical, Baxter, Hospira, and American Regent.

Don’t stop or change your therapy on your own — ask your pharmacist about other manufacturers (see options) and your prescriber about a long-term plan.

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
12
Affected NDCs
5
Reporting manufacturers
5/5
Reporting mfrs supplying
3/3
Affected sizes supplied
8%
NDCs unavailable
1,775
Days in shortage
35,814
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 3, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Sterile Water Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
12 NDCs
Available 10 Limited 1 Unavailable 1
Affected sizes still supplied
Among manufacturers reporting this shortage
3/3 sizes
Sourceable 3
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
5/5 makers
With supply 5
✓ Other manufacturers not reporting a shortage
Still-marketed Sterile Water Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
B. Braun Medical Inc. Baxter Healthcare Company Hospira, Inc. American Regent, Inc. Hikma Pharmaceuticals USA Inc. ICU Medical Inc. Becton Dickinson and Company A-S Medication Solutions Siegfried Hameln GmbH Cardinal Health 107, LLC Chartwell RX, LLC
See all other options & details →
Shortage timeline
  1. Sep 22, 2026
    Currently in shortage
    12 of 12 products affected.
  2. Sep 18, 2026
    FDA refreshed this shortage record
    1 product updated.
  3. Sep 15, 2026
    FDA refreshed this shortage record
    5 products updated.
  4. Aug 4, 2026
    FDA refreshed this shortage record
    1 product updated.
  5. Dec 3, 2021
    More presentations reported
    1 more product added to the shortage.
  6. Nov 23, 2021
    First reported to the FDA
    11 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Fresenius Kabi USA, LLC 📞 888-386-1300 4 NDCS click to expand
Status NDC / product Size Availability Related information Reason
Current Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20) NDC 63323-0185-20 — Available Check wholesalers for inventory —
Current Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50) NDC 63323-0185-50 — Available Check wholesalers for inventory —
Current Sterile Water, Injection, 1000 mL/1000 mL (NDC 63323-178-76) NDC 63323-0178-76 — Available Check wholesalers for inventory —
Current Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10) NDC 63323-0185-10 — Unavailable Next release September 2026. Check wholesalers for inventory. Demand increase for the drug
Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 1 NDC click to expand
Status NDC / product Size Availability Related information Reason
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0641-6147-10) NDC 00641-6147-10 — Available Additional lots will be scheduled for manufacturing. Product will be made available as it is released. —
Manufacturer: Hospira, Inc., a Pfizer Company 📞 844-646-4398 5 NDCS click to expand
Status NDC / product Size Availability Related information Reason
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-50) NDC 00409-4887-50 — Available — —
Current Bacteriostatic Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 0409-3977-03) NDC 00409-3977-03 — Available — —
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-99) NDC 00409-4887-99 — Available — —
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10) NDC 00409-4887-10 — Available — —
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20) NDC 00409-4887-20 — Available — —
Manufacturer: Medefil, Inc. 📞 630-682-4600 1 NDC click to expand
Status NDC / product Size Availability Related information Reason
Current Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30) NDC 64253-0020-30 — Available — —
Manufacturer: Nephron Pharmaceuticals Corporation 📞 800-443-4313 1 NDC click to expand
Status NDC / product Size Availability Related information Reason
Current Sterile Water, Injection, 1 mL/1 mL (NDC 0487-6105-01) NDC 00487-6105-01 — Limited Availability Small amount of inventory available with 12/31/2026 dating Other

These rows are manufacturer reports to the FDA for Sterile Water Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Sterile Water Injection? options further down this page.

Why is Sterile Water Injection in shortage?

Sterile Water for Injection is on the shortage list mainly because demand has gone up — more people need it than the usual supply can keep up with. For Fresenius Kabi, one specific package — the 1 mL/1 mL size (NDC 63323-185-10) — is currently unavailable because of that demand increase, with the next release expected in September 2026. Their other sizes, including another 1 mL/1 mL package and the 1000 mL bag, are still available. Over at Nephron Pharmaceuticals, the 1 mL/1 mL vial is listed as having only limited availability for an unspecified reason, with a small amount of inventory on hand that is dated through December 31, 2026. Hikma Pharmaceuticals noted they are scheduling additional manufacturing runs and will release product as it becomes ready.

It's worth knowing that not every product from every manufacturer is affected — several sizes and packages from multiple companies in this report are still listed as available right now.

FDA reason code(s): Demand increase for the drug; Other

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Sterile Water Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Sterile Water Injection?

Sterile Water Injection is currently on the FDA shortage list, but this is a low-level supply issue, and every strength still has at least one maker reporting it is available.

All three strengths — 1 mL/1 mL, 10 mL/10 mL, and 1000 mL/1000 mL — have an available source right now. None of them are listed as having no source. Within the 1 mL/1 mL strength, one specific lot from one manufacturer is temporarily unavailable with a next release noted for September 2026, but other makers still report supply of that same strength.

The FDA lists the reasons as increased demand and "other." This shortage has lasted over a year, yet all five manufacturers on this record report supply, which is why the overall risk is low. Some notes simply advise checking wholesalers for inventory.

Here is what I suggest:

  • Do not stop, skip, or change how you use this product on your own.
  • Ask your pharmacy to order your strength; they can check wholesalers and other manufacturers.
  • The same medicine is made by several other companies (for example B. Braun, Baxter, ICU Medical, and others), so your pharmacy may be able to source one — though it may not be on the shelf locally.
  • If your exact product can't be found, ask your pharmacist or prescriber about options.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is general national data and may not match local stock.

See “Where else can I get Sterile Water Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Water guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Water guide →

Where else can I get Sterile Water Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Sterile Water Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Sterile Water WATER 1 mL/mL Injection · Intravenous B. Braun Medical Inc. 00264-7385-50
Sterile Water WATER 100 mL/100mL Injection, Solution · Intravenous Baxter Healthcare Company 00338-0013-04
Sterile Water WATER 1 mL/mL Injection · Intramuscular, Intravenous, Subcutaneous Hospira, Inc. 00409-0024-10
Sterile Water WATER 1 mL/mL Injection, Solution · Intravenous American Regent, Inc. 00517-3010-25
Sterile Water WATER 1 mL/mL Injection, Solution · Intramuscular, Intravenous, Subcutaneous Hikma Pharmaceuticals USA Inc. 00641-6147-25
Sterile Water WATER 1 mL/mL Injection, Solution · Intravenous ICU Medical Inc. 00990-7118-07
Sterile Water WATER 1000 mL/1000mL Injection, Solution · Intravenous ICU Medical Inc. 00990-7990-09
Sterile Water WATER 1000 mL/1000mL Injection, Solution · Intravenous Becton Dickinson and Company 17271-0750-07
Sterile Water WATER 1 mL/mL Injection · Intramuscular, Intravenous, Subcutaneous A-S Medication Solutions 50090-2874-01
Water WATER 1 mL/mL Injection, Solution Siegfried Hameln GmbH 52919-0005-05
Sterile Water WATER 1 mL/mL Injection · Intramuscular, Intravenous, Subcutaneous Cardinal Health 107, LLC 55154-0127-05
Sterile Water WATER 1 mL/mL Injection · Intramuscular, Intravenous, Subcutaneous Chartwell RX, LLC 62135-0833-84
Therapeutic equivalents & pricing 21 productsclick to expand

Orange Book–rated equivalents of the affected sizes, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Sterile Water 1 mL/mLNDC 63323-0185-20 Fresenius 25 vials $0.066 AP FDA listed
Sterile Water 1 mL/mLNDC 00409-4887-10 Hospira, 25 vials $0.315 +377% — Availability likely
Sterile Water 1 mL/mLNDC 00409-0024-10 Hospira, 25 vials $0.315 +377% — Availability likely
Sterile Water 1 mL/mLNDC 65219-0187-10 Fresenius 25 vials — AP FDA listed
Sterile Water 1 mL/mLNDC 76420-0082-10 Asclemed 10 ml — — FDA listed
Bacteriostatic Water 1 mL/mLNDC 71872-7129-01 Medical 1 vial — AP FDA listed
Sterile Water 1 mL/mLNDC 72572-0747-10 Civica, 10 vials — AP FDA listed
Sterile Water 1 mL/mLNDC 00404-9971-00 Henry 1 vial — — FDA listed
Sterile Water 1 mL/mLNDC 50090-2874-01 A-S 25 vials — — FDA listed
Sterile Water 1 mL/mLNDC 55154-9588-05 Cardinal 5 vials — AP FDA listed
Sterile Water 1 mL/mLNDC 00641-6147-10 Hikma 10 vials — AP FDA listed
Sterile Water 1 mL/mLNDC 00404-9959-10 Henry 1 vial — — FDA listed
Sterile Water 1 mL/mLNDC 55154-0127-05 Cardinal 5 vials — — FDA listed
Sterile Water 1 mL/mLNDC 84549-0887-50 ProPharma 50 ml — — FDA listed
Bacteriostatic Water 1 mL/mLNDC 00404-9970-30 Henry 1 vial — AP FDA listed
Sterile Water 1 mL/mLNDC 71872-7290-01 Medical 1 vial — — FDA listed
Sterile Water 1 mL/mLNDC 70518-4732-01 REMEDYREPACK 25 vials — — FDA listed
Sterile Water 1 mL/mLNDC 63323-0185-50 Fresenius 25 vials — AP FDA listed
Sterile Water 1000 mL/1000mLNDC 63323-0178-76 Fresenius 1000 ml — AP FDA listed
Sterile Water 1000 mL/1000mLNDC 17271-0750-07 Becton 1000 ml — AP FDA listed
Sterile Water 1000 mL/1000mLNDC 00990-7990-09 ICU 12 pouches — AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Sterile Water Injection — that fall in the same broad treatment class (water) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 001167
GCN 02709
HICL code 000517
Ingredient (HICL) Water For Injection,Sterile
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0B
Therapeutic class — specific (HIC3) Water
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name WATER FOR INJECTION VIAL
FDB brand name Water
Legend status F — Federal legend — prescription drug or device
GPI-1498401010002000
GPI classSterile Water for Injection
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other other shortages

Sterile Water Injection shortage FAQs

Is Sterile Water Injection in shortage?
Yes — the FDA currently lists Sterile Water Injection in shortage (status: “Current”, first reported Nov 23, 2021). 12 of 12 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Sterile Water Injection in shortage?
The manufacturer-reported reason on file with the FDA: Demand increase for the drug; Other. Small amount of inventory available with 12/31/2026 dating.
Which products are affected?
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20) (NDC 63323-0185-20); Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50) (NDC 63323-0185-50); Sterile Water, Injection, 1000 mL/1000 mL (NDC 63323-178-76) (NDC 63323-0178-76). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Sterile Water Injection be available again?
The manufacturer reports: Small amount of inventory available with 12/31/2026 dating. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Sterile Water somewhere?
Other manufacturers (B. Braun Medical Inc., Baxter Healthcare Company, Hospira, Inc. and others) still market it and have not reported a shortage. See “Where else can I get Sterile Water Injection?” above — stock still varies by pharmacy.
What should I do if I take Sterile Water Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Sterile Water Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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