Agency classClass IIOur severity:Severe FDA (Drugs)·D-613-2013·Announced 2013-07-03

Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

Hospira is voluntarily recalling 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 or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the loss of sterility in an intravenous product is a significant hazard.

Plain-English summary

Hospira, Inc. is voluntarily recalling 136,584 units of 0.45% Sodium Chloride Injection, USP, 250 mL. The recall is due to possible leaking bags, which raises a lack of assurance of sterility for the product.

The affected product is identified by Lot # 93-153-JT with an expiration date of 9/12. The distribution pattern includes nationwide distribution, Puerto Rico, U.S. Virgin Island, Libya, and Saudi Arabia.

Consumers and healthcare providers should stop using the affected product and contact Hospira, Inc. for further instructions or a replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Hospira Inc.
Category: Drug — Intravenous Solution
Hazard: sterility
leaking
Affected units: 136,584

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 #: 93-153-JT
Exp 9/12

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 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 →

Same brand · SODIUM CHLORIDE

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Critical
Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
High
Spectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
High
Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16

Same hazard · sterility