FDA Drug recall D-0554-2026
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Ko…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Ko… by Spectra Medical Devices, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0554-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Spectra Medical Devices |
| Distribution | US |
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
Identifiers
| ndc | 65282-1605-1 |
|---|---|
| code_info | Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0554-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.