Huons Co., Ltd.: Lidocaine Hcl Injection, Usp, 1% 50mg/5ml (10 Mg/ml)
Recall Summary Lidocaine HCl injection (a local anesthetic) manufactured by Huons Co., Ltd. and distributed nationwide under multiple brand names and NDC numbers is being recalled because the manufacturer cannot guarantee the product is sterile. This Class II recall affects vials and cartons distributed across all U.S. states and territories by McKesson Corporation, Brookefield Pharmaceuticals, and Novagenix Labs.
- Recalling firm
- Huons Co., Ltd.
- Product
- Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC...
- 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/fcd6020e-150f-4b50-9256-708522c24083