Agency classClass IOur severity:Severe FDA (Drugs)·D-1162-2014·Announced 2014-03-26

Baxter Recalls 5% Dextrose Injection Due to Particulate Matter

Baxter Healthcare is voluntarily recalling 105,216 containers of 5% Dextrose Injection due to the presence of particulate matter, including fibers and plastic particles.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Baxter Healthcare Corporation is issuing a voluntary recall of 5% Dextrose Injection, USP, 100 mL single-dose VIAFLEX plastic containers. The recall involves 105,216 containers from Lot P285288, which has an expiration date of 11/13. The product is distributed nationwide, as well as in Puerto Rico, Singapore, Saudi Arabia, and the United Arab Emirates.

The recall is being conducted due to the presence of particulate matter in the solution. The identified particles include polyester and cotton fibers, an adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene, and human hair embedded in the plastic bag.

Healthcare providers and patients should stop using the affected product. Baxter Healthcare is the recalling firm responsible for this action.

The recalled product

Product: DEXTROSE (DEXTROSE MONOHYDRATE)
Brand: DEXTROSE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: particulate-matter
contamination
Affected units: 105,216

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: P285288
Exp 11/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · DEXTROSE

Severe
Dextrose Injection USP recalled due to sterility assurance concerns
FDA (Drugs) · 2026-04-29
High
Fresenius Kabi 50 mL dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 100 mL dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 5% dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Severe
Pfizer 5% Dextrose Injection Recalled for Potential Bag Leakage
FDA (Drugs) · 2021-12-08

Same manufacturer · Baxter Healthcare Corp.

See all →

High
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
Moderate
Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
Moderate
Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
Moderate
Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
High
Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16

Same hazard · particulate matter