Hospira Recalls Lidocaine/Dextrose Ampules for Stability Failure
Hospira recalls specific lots of 5% Lidocaine HCL and 7.5% Dextrose Injection due to failed stability specifications regarding color and pH.
Use caution until it’s fixed
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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What happened, in plain English
Hospira Inc. is recalling 287,200 units of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL single-dose ampules because they did not meet stability specifications for color and pH throughout their shelf life. The affected products are intended for spinal anesthesia. The recall record does not specify a remedy or action steps for consumers. Read more at govinfonow.com/recall/42566-hospira-recalls-lidocaine-dextrose-ampules-for-stability-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42566-hospira-recalls-lidocaine-dextrose-ampules-for-stability-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0169-2017
Cite this page
“Hospira Recalls Lidocaine/Dextrose Ampules for Stability Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42566-hospira-recalls-lidocaine-dextrose-ampules-for-stability-failure. Based on FDA recall #D-0169-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2017%22&limit=1).
Why it’s dangerous
The recalled lots failed to meet specifications for color and pH. While the record does not detail specific injuries, deviations in these chemical properties can affect the safety and efficacy of a medication intended for spinal anesthesia.
Who’s affected
This recall affects medical facilities, pharmacies, and healthcare providers in the US and Puerto Rico that stock or dispense this specific prescription drug for spinal anesthesia.
How to tell if you have this one
Check if you have 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL single-dose ampules in a 5-count box manufactured by Hospira Inc. Look for NDC 0409-4712-01 and Lot numbers starting with 34-547-DK (Exp. 10/16) or 39-372-DK (Exp. 03/17), potentially followed by numbers 01 to 99.
- Brand
Hospira- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The distribution pattern includes the US and Puerto Rico.
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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-0169-2017 (June 29, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0169-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.