Notice names this product. Spectra Medical Devices’s Lidocaine HCl Injection USP is named in FDA Class II recall D-0554-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Lack of Assurance of Sterility Identifying details: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.. Units affected: 210625 ampules. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Lack of Assurance of Sterility
Company / brand: Spectra Medical Devices
Affected product: Lidocaine HCl Injection USP
Official ID D-0554-2026 · Official record ↗
See all Spectra Medical Devices recalls →
Found something wrong or missing? Report a data error.
Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.