Agency classClass IIOur severity:Severe FDA (Drugs)·D-0496-2026·Announced 2026-04-29

Dextrose Injection USP recalled due to sterility assurance concerns

B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

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: This is an FDA Class II recall of a sterile injectable drug with potential for microbial contamination (lack of sterility assurance) and product leakage—hazards that could result in serious adverse health consequences including infection in vulnerable patients receiving intravenous therapy.

Plain-English summary

B. Braun Medical Inc. is recalling Dextrose Injection USP, 70%, in 2000 mL bags (NDC: 0264-7387-50) nationwide. The recall affects 17,124 bags from Lots J5H166 and J5H167 with an expiration date of November 30, 2026.

The product is being recalled due to lack of assurance of sterility and potential for leakage from the diaphragm port once the foil is removed. This intravenous medication is distributed nationwide.

Patients and healthcare providers who have this product should not use affected lots. Contact B. Braun Medical Inc. or the FDA for guidance on proper handling and replacement options.

The recalled product

Product: DEXTROSE (DEXTROSE)
Brand: DEXTROSE
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Intravenous Injection
Hazard: sterility-assurance
contamination-risk
leakage
Affected units: 17,124

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 (3)

Lot # J5H166
J5H167
Exp Date: 30NOV2026.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by B BRAUN MEDICAL INC 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 4 products in this recall →

Same brand · DEXTROSE

High
Fresenius Kabi 50 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
High
Fresenius Kabi 100 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
Moderate
Pfizer Recalls Dextrose Injection Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2019-12-18

Same manufacturer · B BRAUN MEDICAL INC

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Same hazard · sterility assurance