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Sterile Water Injection shortage

Current  12 presentations ยท 5 manufacturers ยท first FDA posting 2021-11-23 ยท last update 2026-10-15

Manufacturers: Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA, Inc., Hospira, Inc., a Pfizer Company, Medefil, Inc., Nephron Pharmaceuticals Corporation

Stated reasons (per FDA): Demand increase for the drug; Other

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Sterile Water, Injection, 1000 mL/1000 mL (NDC 63323-178-76)Fresenius Kabi USA, LLCCurrent
Available
โ€”Check wholesalers for inventoryPosted 11/23/2021
Updated 10/15/2026
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10)Fresenius Kabi USA, LLCCurrent
Unavailable
Demand increase for the drugNext release October 2026. Check wholesalers for inventory.Posted 11/23/2021
Updated 10/15/2026
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20)Fresenius Kabi USA, LLCCurrent
Available
โ€”Check wholesalers for inventoryPosted 11/23/2021
Updated 10/15/2026
Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50)Fresenius Kabi USA, LLCCurrent
Available
โ€”Check wholesalers for inventoryPosted 11/23/2021
Updated 10/15/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0641-6147-10)Hikma Pharmaceuticals USA, Inc.Current
Available
โ€”Additional lots will be scheduled for manufacturing. Product will be made available as it is released.Posted 11/23/2021
Updated 09/18/2026
Bacteriostatic Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 0409-3977-03)Hospira, Inc., a Pfizer CompanyCurrent
Available
โ€”Posted 12/03/2021
Updated 10/08/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10)Hospira, Inc., a Pfizer CompanyCurrent
Available
โ€”Posted 11/23/2021
Updated 10/08/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20)Hospira, Inc., a Pfizer CompanyCurrent
Available
โ€”Posted 11/23/2021
Updated 10/08/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-50)Hospira, Inc., a Pfizer CompanyCurrent
Available
โ€”Posted 11/23/2021
Updated 10/08/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-99)Hospira, Inc., a Pfizer CompanyCurrent
Available
โ€”Posted 11/23/2021
Updated 10/08/2026
Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30)Medefil, Inc.Current
Available
โ€”Posted 11/23/2021
Updated 10/15/2026
Sterile Water, Injection, 1 mL/1 mL (NDC 0487-6105-01)Nephron Pharmaceuticals CorporationCurrent
Limited Availability
OtherSmall amount of inventory available with 12/31/2026 datingPosted 11/23/2021
Updated 08/04/2026

Source: FDA Drug Shortages Database ยท raw openFDA records

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