FDAFDA · Food and drugs·Recall number D-0554-2026
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.
Published June 10, 2026 · Recall initiated: May 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Spectra Medical Devices, Llc
- Distributor
- USA Nationwide
- UPC
- 0365282160515
- Lot
- Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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