Agency classClass IIOur severity:Severe FDA (Drugs)·D-0972-2017·Announced 2017-07-19

Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical products, are rated as Severe (4).

Plain-English summary

Baxter Healthcare Corporation is recalling 54,528 bags of 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container. The product is identified by Lot P361618 and has an expiration date of 09/30/18.

The recall was initiated because the bags have the potential to leak, which creates a lack of assurance of sterility. This defect poses a risk to patients who receive the intravenous solution.

The affected product was distributed nationwide, in Puerto Rico, and in Saudi Arabia. Healthcare providers and patients should stop using the recalled product and contact Baxter Healthcare for further instructions.

The recalled product

Product: DEXTROSE (DEXTROSE MONOHYDRATE)
Brand: DEXTROSE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — IV Solution
Hazard: sterility
leakage
Affected units: 54,528

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: P361618
Exp 09/30/18

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 Corporation 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 5% 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 50 mL 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 Corporation

See all →

Moderate
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Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · sterility