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Prescription medicine · generic available

Dextrose monohydrate

Brand names: Infant Dextrose

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

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

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
Current shortageFDA shortage list
14Recalls (FDA reports)
14Companies
1971First FDA approval on file

Quick answers

What is Dextrose monohydrate used for?
The FDA-approved label (Infant Dextrose, Henry Schein, Inc., July 13, 2026) says: “Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Dextrose monohydrate have a boxed warning?
No. None of the 39 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Dextrose monohydrate?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
Has Dextrose monohydrate been recalled?
FDA enforcement reports list 14 recalls of products of this medicine; the newest started March 11, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Dextrose monohydrate?
14 companies list prescription products of Dextrose monohydrate in the FDA NDC Directory, including Baxter Healthcare Corporation, Fresenius Kabi USA, LLC and ICU Medical Inc..

What Dextrose monohydrate is used for

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

Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old.

— FDA label: Infant Dextrose, Henry Schein, Inc., effective July 13, 2026. Read the full label on DailyMed →

The FDA has 39 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.

0 of 39 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection · Injection, solution, concentrate
RouteIntravenous
Prescription products73 in the FDA NDC Directory
Brand namesInfant Dextrose

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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA016367
DEXTROSE 5% IN PLASTIC CONTAINER		 Otsuka Icu MedclFebruary 12, 1971 150, latest June 9, 2025
2025: Labeling · 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC)
NDA016673
DEXTROSE 5% IN PLASTIC CONTAINER		 Baxter HlthcareMarch 4, 1971 105, latest June 11, 2026
2026: Labeling · 2024: Manufacturing (CMC) · 2019: Labeling
NDA016694
DEXTROSE 10% IN PLASTIC CONTAINER		 Baxter HlthcareJanuary 25, 1971 89, latest June 11, 2026
2026: Labeling · 2020: Manufacturing (CMC) · 2019: Labeling
NDA016730
DEXTROSE 5% IN PLASTIC CONTAINER		 B BraunDecember 21, 1973 44, latest May 12, 2026
2026: Labeling · 2014: Manufacturing (CMC) · 2006: Labeling
NDA018080
DEXTROSE 10% IN PLASTIC CONTAINER		 Otsuka Icu MedclAugust 28, 1979 75, latest June 9, 2025
2025: Labeling · 2014: Manufacturing (CMC) · 2008: Labeling
NDA018561
DEXTROSE 70% IN PLASTIC CONTAINER		 Otsuka Icu MedclMarch 23, 1982 38, latest May 14, 2018
2018: Labeling · 2016: Labeling · 2003: Labeling
NDA018562
DEXTROSE 40% IN PLASTIC CONTAINER		 Otsuka Icu MedclMarch 23, 1982 37, latest May 14, 2018
2018: Labeling · 2016: Labeling · 2003: Labeling
NDA018563
DEXTROSE 50% IN PLASTIC CONTAINER		 Otsuka Icu MedclMarch 23, 1982 38, latest May 14, 2018
2018: Labeling · 2016: Labeling · 2003: Labeling
NDA018564
DEXTROSE 20% IN PLASTIC CONTAINER		 Otsuka Icu MedclMarch 23, 1982 37, latest May 14, 2018
2018: Labeling · 2016: Labeling · 2003: Labeling
NDA019345
DEXTROSE 30% IN PLASTIC CONTAINER		 Otsuka Icu MedclJanuary 26, 1985 27, latest May 14, 2018
2018: Labeling · 2016: Labeling · 2003: Labeling
NDA019445
DEXTROSE 25%, DEXTROSE 50%		 HospiraJune 3, 1986 4, latest July 25, 2025
2025: Labeling · 2025: Labeling · 1998: Efficacy
NDA019466
DEXTROSE 5% IN PLASTIC CONTAINER		 HospiraJuly 15, 1985 37, latest June 6, 2025
2025: Labeling · 2019: Manufacturing (CMC) · 2016: Labeling
NDA019893
DEXTROSE 70% IN PLASTIC CONTAINER		 Otsuka Icu MedclDecember 26, 1989 14, latest December 18, 2003
2003: Labeling · 2002: Manufacturing (CMC) · 1999: Labeling
NDA020047
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE 70% IN PLASTIC CONTAINER		 Baxter HlthcareJuly 2, 1991 20, latest August 5, 2019
2019: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC)
NDA020179
DEXTROSE 5% IN PLASTIC CONTAINER		 Baxter HlthcareDecember 7, 1992 9, latest December 7, 2022
2022: Manufacturing (CMC) · 2019: Labeling · 2019: Labeling

Generic approvals (3)

Shortage status

Current shortage · updated October 27, 2026 · first posted January 13, 2022

ProductDextrose Monohydrate 50%, Injection, 25 g/50 mL (NDC 0409-6648-02)
AvailabilityLimited Availability
Reason givenOther
CompanyHospira, 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.

  1. March 11, 2026 · Class II · Ongoing · D-0436-2026

    Lack of Assurance of Sterility

    5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. — Fresenius Kabi USA, LLC

  2. March 11, 2026 · Class II · Ongoing · D-0435-2026

    Lack of Assurance of Sterility

    5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60. — Fresenius Kabi USA, LLC

  3. March 11, 2026 · Class II · Ongoing · D-0437-2026

    Lack of Assurance of Sterility

    5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30. — Fresenius Kabi USA, LLC

  4. November 30, 2021 · Class II · Terminated · D-0265-2022

    Lack of sterility assurance: bag has the potential to leak.

    5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66 — Pfizer Inc.

  5. November 27, 2019 · Class II · Terminated · D-0577-2020

    Labeling: Incorrect or Missing Lot and/or expiration date.

    25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10 — Pfizer Inc.

  6. July 6, 2017 · Class II · Terminated · D-0972-2017

    Lack of Assurance of Sterility: Bags have the potential to leak.

    5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38 — Baxter Healthcare Corporation

  7. April 21, 2017 · Class I · Ongoing · D-0862-2017

    Presence of Particulate Matter: human hair found within an internal sample syringe.

    Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10 — Hospira Inc.

  8. December 15, 2015 · Class I · Terminated · D-0958-2016

    Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

    Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-071 — Baxter Healthcare Corp.

  9. March 24, 2015 · Class I · Terminated · D-1209-2015

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL — Baxter Healthcare Corp.

  10. March 24, 2015 · Class I · Terminated · D-1210-2015

    Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

    10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL — Baxter Healthcare Corp.

  11. March 18, 2015 · Class II · Terminated · D-0426-2015

    Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

    5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation — Baxter Healthcare Corp.

  12. March 5, 2015 · Class II · Terminated · D-0417-2015

    Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

    5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Fores — Hospira Inc.

  13. November 21, 2013 · Class I · Terminated · D-1162-2014

    Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

    5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. — Baxter Healthcare Corp.

  14. May 21, 2013 · Class II · Terminated · D-625-2013

    Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

    5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015 — Baxter Healthcare Corp.

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)237649, 237650, 237656, 242694, 727517, 727518, 1795477, 1795480, 1795481, 1795514 … (+8)
SPL set ID of the quoted labelce71d929-d11e-444c-bd45-e025d5172057
FDA labels (SPL)39
FDA applicationsNDA016367, NDA016673, NDA016694, NDA016730, NDA018080, NDA018561, NDA018562, NDA018563, NDA018564, NDA019345, NDA019445, NDA019466, NDA019893, NDA020047, NDA020179, 3 ANDA
Active ingredients (FDA)DEXTROSE MONOHYDRATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Infant Dextrose, Henry Schein, Inc., effective July 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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