Lidocaine HCl Injection — Class II drug recall D-0532-2026
Ongoing recall by Huons Co., Ltd., reported 2026-04-22, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0532-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Huons Co., Ltd., Jecheon, N/A, Korea (the Republic of) |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 68094-0081, 68094-0081-01, 68094-0081-25, 71351-0021, 71351-0021-05, 71351-0021-10, 71351-0021-25, 71351-0023, 71351-0023-05, 71351-0023-10, 71351-0023-25, 71351-0026, 71351-0026-20, 71351-0026-25, 71351-0027, 71351-0027-20, 71351-0027-25, 73293-0001, 73293-0001-01, 73293-0001-02, 73293-0003, 73293-0003-01, 73293-0003-02, 73293-0004, 73293-0004-01 and 10 more |
Product
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
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-0532-2026. 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.