Hospira Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While no specific injuries are reported in the text, the potential loss of sterility in an IV product is a significant health risk that aligns with the upper end of Class II severity.
Plain-English summary
Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container. The affected product is identified by Lot # 11-161-JT with an expiration date of 11/13. The recall is being conducted due to possible leaking bags, which raises concerns regarding the assurance of sterility.
The affected units were distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected product and contact Hospira Inc. for further instructions or replacement. This recall is classified as FDA Class II.
The recalled product
- Product
- 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 74,256
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 #: 11-161-JT
- Exp 11/13
Distribution
Part of a larger recall action
This product is one of 9 recalled by Hospira 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 9 products in this recall →Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereHospira Recalls IV Bags Due to Potential Sterility Breach
FDA (Drugs) · 2014-12-03
- SevereHospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags
FDA (Drugs) · 2014-12-03
- SevereHospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2015-01-14
- SevereHospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2014-12-03
- SevereHospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-03
- HighHospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-03