Huons Co., Ltd. recalls Lidocaine HCl injection
- Recalling company
- 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 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 2, 2026
- Reported
- Apr 22, 2026
- Distribution
- USA Nationwide.
- Status
- Ongoing
- Quantity
- 33,599,925 ampules and 23658125 vials
- Lot / codes
- All lots within expiry
- Company location
- Jecheon, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0529-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0529-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.