FDA recall, , Moderate risk
Spectra Medical Devices Lidocaine HCl Injection
Lidocaine HCl Injection USP may lack sterility.
Summary by Recall Canary from the FDA notice
What happened
Spectra Medical Devices, LLC of Wilmington, Massachusetts is recalling Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, distributed nationwide, because of a lack of assurance of sterility. The recall began on May 12, 2026, and was added to the FDA's Enforcement Report on June 2, 2026.
The product is described as Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules
- NDC
- 65282-1605-1
- Lot code
- AE4013
- AE5032
- AE5039
- AE5104
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Spectra Medical Devices, LlcWilmington, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98976
- Recall number
- D-0554-2026
- Quantity recalled
- 210625 ampules
All recalls from Spectra Medical Devices, Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
