Lidocaine HCl Injection USP — Class II drug recall D-0554-2026
Ongoing recall by Spectra Medical Devices, Llc, reported 2026-06-10, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0554-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectra Medical Devices, Llc, Wilmington, MA, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-06-02 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 210,625 ampules |
| Reason classes | sterility |
| NDC | 65282-1605, 65282-1605-01 |
| Lot numbers | AE4013, AE5032, AE5039, AE5104 |
| Expiration dates | 2027-01-31, 2028-03-31, 2028-08-31 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0554-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.