Hospira Recalls Normosol-M Injection Due to Labeling Error
Hospira Inc. recalls 10,778 bags of Normosol-M and 5% Dextrose Injection due to an incorrect expiration date on the label.
Use caution until it’s fixed
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
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What happened, in plain English
Hospira Inc. is recalling Normosol-M and 5% Dextrose Injection Type 1, USP in 1000 mL single-dose containers. The issue involves a labeling error where the printed expiration date was incorrect. Specifically, one bag was labeled with an expiration date of 01AUG1017 instead of the correct date of 01AUG2017. Read more at govinfonow.com/recall/43201-hospira-recalls-normosol-m-injection-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/43201-hospira-recalls-normosol-m-injection-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0727-2016
Cite this page
“Hospira Recalls Normosol-M Injection Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43201-hospira-recalls-normosol-m-injection-due-to-labeling-error. Based on FDA recall #D-0727-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2016%22&limit=1).
Why it’s dangerous
The primary container was printed with an incorrect expiration date (01AUG1017) instead of the correct one (01AUG2017). This labeling error could lead to confusion regarding the product's usability and safety, potentially causing healthcare professionals to administer a product that may be past its intended shelf life or discard a safe product.
Who’s affected
Healthcare providers and patients who received or used the specific lot of Normosol-M Injection Type 1, USP distributed nationwide and in Hong Kong. The risk is primarily related to medication administration based on incorrect expiration information.
How to tell if you have this one
Check for Normosol-M and 5% Dextrose Injection Type 1, USP in 1000 mL single-dose containers. Look for NDC 0409-7965-09, Barcode (01) 0 030409 796509 0, and Lot # 56-853-FW. Verify if the expiration date printed on the bag is 01AUG1017.
- Brand
Hospira- Category
Drug
What to do — step by step
Identify Affected Product
Check inventory for Normosol-M and 5% Dextrose Injection Type 1, USP with Lot # 56-853-FW and NDC 0409-7965-09.
Verify Expiration Date
Inspect the primary container to see if it is labeled with the incorrect expiration date of 01AUG1017.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Hong Kong” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0727-2016 (February 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0727-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.