Recall archive / FDA drug enforcement

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wil... — FDA record D-0554-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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.
Reason: Lack of Assurance of Sterility
Classification: Class II
Recalling firm: Spectra Medical Devices, Llc
Quantity: 210625 ampules
Agency-reported status: Ongoing
Source record identifier: D-0554-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

USA Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 10, 2026
Recall initiation date: May 12, 2026
Center classification date: Jun 2, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.