B. Braun Recalls 5% Dextrose Injection Due to Fungal Contamination
B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP due to non-sterility caused by fungal contamination from leaking containers.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP, 100mL in a 150 mL PAB container. The product is identified by NDC 00264-1510-32, Lot # J5J706, and an expiration date of 10/31/2016.
The recall was initiated due to non-sterility, specifically fungal contamination resulting from leaking containers. The affected units were distributed nationwide.
Healthcare providers and patients should stop using the recalled product immediately. Consumers should contact their healthcare provider for further instructions on how to proceed.
The recalled product
- Product
- 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Affected units
- 57,408
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 #: J5J706
- Exp. 10/31/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · B. Braun Medical Inc
See all →- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
Similar recalls
- SevereDextrose Injection USP recalled due to sterility assurance concerns
FDA (Drugs) · 2026-04-29
- SevereBaxter Recalls 5% Dextrose Injection Due to Sterility Concerns
FDA (Drugs) · 2015-04-01
- SevereSterRx Sodium Bicarbonate Injection Recalled for Non-Sterility
FDA (Drugs) · 2021-09-01
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- SevereBaxter Recalls Dextrose Injection Due to Insect Contamination
FDA (Drugs) · 2016-06-15
- SevereHospira Recalls 5% Dextrose Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-03