Lidocaine HCl Injection — Class II drug recall D-0573-2020
Terminated recall by AuroMedics Pharma LLC, reported 2019-12-04, distributed nationwide. Presence of Foreign Substance: Foreign material found inside the vial.
| Recall number | D-0573-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-11-11 |
| Classified | 2019-12-05 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 111,850 vials |
| Reason classes | foreign material |
| NDC | 00409-1162-18, 55150-0165-05, 67777-0419-02, 80425-0573, 80425-0573-01 |
| Lot numbers | CLC190049 |
| Expiration dates | 2022-02 |
Product
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Reason for recall
Presence of Foreign Substance: Foreign material found inside the vial.
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-0573-2020. 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.