Huons Co., Ltd.: Lidocaine Hcl Injection, Usp, 2%, 100 Mg/5ml (20 Mg/ml)
Recall Summary Lidocaine HCl Injection 2% (a local anesthetic) manufactured by Huons Co., Ltd. and distributed under multiple brand names nationwide is being recalled because there is no assurance the product is sterile. The recalled product comes in 5 mL single-dose vials with various NDC numbers depending on the distributor. This recall affects healthcare facilities and providers across all U.S. states and Washington, D.C.
- Recalling firm
- 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...
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/4a635a42-d854-472f-97e6-ece9c0a856ee