Spectra Medical Recalls Lidocaine Ampules Due to Sterility Risk
Spectra Medical Devices recalls Lidocaine HCl Injection ampules due to lack of sterility assurance. Check lot numbers AE4013, AE5032, AE5039, and AE5104.
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Lack of Assurance of Sterility
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What happened, in plain English
Spectra Medical Devices, LLC is recalling Lidocaine HCl Injection USP single-dose ampules because there is a lack of assurance that the product is sterile. The recall affects approximately 210,625 ampules distributed nationwide in the USA. This issue was identified and reported on May 12, 2026. Read more at govinfonow.com/recall/31310-spectra-medical-recalls-lidocaine-ampules-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31310-spectra-medical-recalls-lidocaine-ampules-due-to-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0554-2026
Cite this page
“Spectra Medical Recalls Lidocaine Ampules Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31310-spectra-medical-recalls-lidocaine-ampules-due-to-sterility-risk. Based on FDA recall #D-0554-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0554-2026%22&limit=1).
Why it’s dangerous
The primary hazard is the lack of assurance of sterility in the single-dose ampules. If the product is not sterile, injecting it into a patient could introduce bacteria or other contaminants, potentially causing severe infection or other serious medical complications.
Who’s affected
Healthcare providers and patients who have received or are using Lidocaine HCl Injection USP from Spectra Medical Devices. Individuals at risk include those who might receive non-sterile injections, which can lead to serious infections.
How to tell if you have this one
Check if you have Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, distributed by Spectra Medical Devices, LLC. Look for the following lot numbers and expiration dates: Lot AE4013 (Exp 1/31/2027), Lots AE5032 & AE5039 (Exp 3/31/2028), and Lot AE5104 (Exp 8/31/2028). The NDC is 65282-1605-1.
- Brand
Spectra Medical Devices- Category
Drug
What to do — step by step
Stop using the product
Do not use any ampules matching the recalled lot numbers due to the sterility risk.
Contact your supplier
Reach out to the distributor or vendor where the product was purchased for further instructions on return or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the specific hazard with this recall?
The recalled ampules have a lack of assurance of sterility, meaning they may not be free from microorganisms.
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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-0554-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0554-2026 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.