Quick Facts at a Glance
- Recall Date
- May 12, 2026
- Hazard Level
- HIGH
- Brands
- LIDOCAINE HYDROCHLORIDE, Spectra Medical Devices, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LIDOCAINE HYDROCHLORIDE, Spectra Medical Devices, LLC
- Model numbers
- Lot#: AE4013, Exp 1/31/2027, AE5032 & AE5039, Exp 3/31/2028, AE5104, Exp 8/31/2028.
- UPC codes
- 65282-1605, 65282-1605-1
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 12, 2026
Reported by FDA DRUG
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Spectra Medical Devices, Llc or your healthcare provider for guidance. Notification method: Letter
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Full Description
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.. Generic: LIDOCAINE HYDROCHLORIDE ANHYDROUS; Brand: LIDOCAINE HYDROCHLORIDE. Reason: Lack of Assurance of Sterility. Classification: Class II. Quantity: 210625 ampules. Distribution: USA Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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