Baxter Recalls 5% Dextrose Injection Bags Due to Metal Particulate Matter
Baxter Healthcare is recalling 402,284 bags of 5% Dextrose Injection due to the presence of metal particulate matter.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Baxter Healthcare Corporation is recalling 402,284 bags of 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags. The recall is due to the presence of particulate matter, specifically metal, in the product.
The affected product is identified by Lot numbers C963413 and C963413A, with an expiration date of 7/31/2016. The product was distributed in the United States, Puerto Rico, and Bermuda. The product is an intravenous prescription drug manufactured by Baxter Healthcare Corporation.
Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Intravenous Solution
- Affected units
- 402,284
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 #: C963413 and C963413A
- Exp 7/31/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same brand · DEXTROSE
- SevereDextrose Injection USP recalled due to sterility assurance concerns
FDA (Drugs) · 2026-04-29
- HighFresenius Kabi 50 mL dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 100 mL dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 5% dextrose injection bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- SeverePfizer 5% Dextrose Injection Recalled for Potential Bag Leakage
FDA (Drugs) · 2021-12-08
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26