Sterile Water Injection Shortage: FDA Status Update
Areazine synthesizes this FDA drug-shortage notice directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Sterile Water Injection is currently listed in the FDA Drug Shortage Database, with availability from several manufacturers as of the latest update.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on April 7, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Drug Shortages - determines the regulatory framework behind it, which shapes what mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Sterile Water Injection) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
Sterile Water Injection Shortage Update
We at Areazine understand that reliable access to medications like Sterile Water Injection is essential for many patients, and we aim to provide clear, factual information without causing undue concern.
What's in Shortage
The generic drug name is Sterile Water Injection. The brand name is STERILE WATER. It is available in injection dosage form. The current status is listed as current in the FDA database. It falls under the therapeutic category of Other. The shortage was first posted on 11/23/2021 and last updated on 03/27/2026.
Which Manufacturers Are Affected
Several manufacturers have reported availability for Sterile Water Injection:
- Hospira, Inc., a Pfizer Company: Available for presentations such as Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10), with contact info at 844-646-4398.
- Fresenius Kabi USA, LLC: Available for presentations such as Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50) and (NDC 63323-185-20), with related info to check wholesalers for inventory and contact info at 888-386-1300.
- Hospira, Inc., a Pfizer Company: Also available for Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20) and (NDC 0409-4887-50) and (NDC 0409-4887-99), with contact info at 844-646-4398.
- Medefil, Inc.: Available for Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30), with contact info at 630-682-4600.
- Fresenius Kabi USA, LLC: Available for Sterile Water, Injection, 1000 mL/1000 mL (NDC 63323-178-76), with related info to check wholesalers for inventory and contact info at 888-386-1300.
Why There's a Shortage
No specific reason was given for the shortage in the available data.
What Patients Should Do
If you rely on Sterile Water Injection, we recommend speaking with your pharmacist or healthcare provider to check current availability and discuss your options. You may also contact the relevant manufacturers directly using the provided information. Remember, patients should always consult their healthcare provider for any medical concerns and not make changes to their treatment based on this article alone.
Source
This information is sourced from the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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