Lidocaine HCl Injection Recall: Huons 2% 5 mL Vials
Announced 2026-04-22 · FDA
This recall covers Lidocaine HCl Injection, USP, 2%, 5 mL single-dose vials (100 mg/5 mL), Rx only, manufactured by Huons Co., Ltd., and distributed nationwide in the USA. The recall is due to lack of assurance of sterility. All lots within expiry are included.
| Brand | Huons Co., Ltd. |
|---|---|
| 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 | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 7120750 |
| Distribution | USA Nationwide. |
| Agency | FDA |
| Recall / campaign no. | All lots within expiry |
WHAT YOU SHOULD DO
- Do not use this product.
- Contact your healthcare provider or supplier for disposal or replacement instructions.
- If you have used the product, monitor for adverse effects and seek medical advice if concerned.
- Follow instructions from the facility or distributor regarding return or disposal.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.