thejoe Dextrose Monohydrate

Dextrose Monohydrate recalls: 14 FDA reports

Recalls involving Dextrose Monohydrate. What was wrong with each batch, and how the FDA graded the risk.

14Reports

5Class I

4Ongoing

2026-04-15Most recent

5 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	9
Class I	5

By year reported

Year	Reports
2013	1
2014	1
2015	4
2016	1
2017	2
2019	1
2021	1
2026	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

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,

D-0435-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 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.
Where it went: US Nationwide , Alaska, and Puerto Rico.

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi US

D-0437-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 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.
Where it went: US Nationwide , Alaska, and Puerto Rico.

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA,

D-0436-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 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.
Where it went: US Nationwide , Alaska, and Puerto Rico.

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 600

D-0265-2022 · Class II · reported 2021-12-08 · Terminated

Why it was recalled: Lack of sterility assurance: bag has the potential to leak.
Product: 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
Where it went: USA Nationwide
How much: 765 bags

25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 6

D-0577-2020 · Class II · reported 2019-12-18 · Terminated

Why it was recalled: Labeling: Incorrect or Missing Lot and/or expiration date.
Product: 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
Where it went: Nationwide within the United States including Puerto Rico.
How much: 77,100 syringes

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfie

D-0972-2017 · Class II · reported 2017-07-19 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Bags have the potential to leak.
Product: 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
Where it went: Nationwide, Puerto Rico and Saudi Arabia
How much: 54,528 bags

Class I

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx on

D-0862-2017 · Class I · reported 2017-05-31 · Ongoing

Why it was recalled: Presence of Particulate Matter: human hair found within an internal sample syringe.
Product: 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
Where it went: Nationwide in the USA and Puerto Rico
How much: 71,550 syringes

Class I

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusi

D-0958-2016 · Class I · reported 2016-06-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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 0338-0719-06
Where it went: Nationwide
How much: 28,080 VIAFLEX Plastic Containers

Class I

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts

D-1209-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: 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 60015-4625. NDC 0338-0017-02
Where it went: US, Puerto Rico, and Bermuda
How much: 402,284 bags

Class I

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pit

D-1210-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: 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 60015-4625. NDC 0338-0023-02
Where it went: US, Puerto Rico, and Bermuda
How much: 18,324 bags

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Co

D-0426-2015 · Class II · reported 2015-04-01 · Terminated

Why it was recalled: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Product: 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, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
Where it went: Nationwide
How much: 48,874

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged

D-0417-2015 · Class II · reported 2015-03-25 · Terminated

Why it was recalled: Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Product: 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 Forest, IL 60045.
Where it went: Nationwide
How much: 94,440 bags

Class I

5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporat

D-1162-2014 · Class I · reported 2014-03-26 · Terminated

Why it was recalled: 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
Product: 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.
Where it went: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
How much: 105,216 containers

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b)

D-625-2013 · Class II · reported 2013-07-10 · Terminated

Why it was recalled: 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.
Product: 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
Where it went: Nationwide & Puerto Rico
How much: 730,848 units

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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