Lidocaine Hydrochloride Solution
FDA Recall NDC 73293-0004
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Lidocaine Hydrochloride (NDC 73293-0004). A significant event, classified as Class II, was initiated on Apr 02, 2026 by Huons Co., Ltd.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Apr 02, 2026
Apr 22, 2026
33,599,925 ampules and 23658125 vials
Recall Profile & Regulatory Data
Event ID
98724
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Huons Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
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)
Batch or Lot Expiration Information
Lot# All lots within expiry
Affected Packages Involved in this Recall
73293-0004-1Product
73293-0004-2Product
73293-0005-1Product
73293-0005-2Product
73293-0001-1Product
73293-0001-2Product
73293-0003-1Product
73293-0003-2Product
63739-170-13Product
63739-170-24Product
63739-170-27Product
71351-026-20Product
71351-026-25Product
71351-027-20Product
71351-027-25Product
71351-021-05Product
71351-021-10Product
71351-021-25Product
71351-023-05Product
71351-023-10Product
71351-023-25Product
84769-0001-1Product
84769-0001-2Product
84769-0002-1Product
84769-0002-2Product
Class II Ongoing
Lack of Assurance of Sterility
Apr 02, 2026
Apr 22, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98724
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Huons Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
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)
Batch or Lot Expiration Information
Lot# All lots within expiry
Affected Packages Involved in this Recall
73293-0004-1Product
73293-0004-2Product
73293-0005-1Product
73293-0005-2Product
73293-0001-1Product
73293-0001-2Product
73293-0003-1Product
73293-0003-2Product
71351-026-20Product
71351-026-25Product
71351-027-20Product
71351-027-25Product
71351-021-05Product
71351-021-10Product
71351-021-25Product
71351-023-05Product
71351-023-10Product
71351-023-25Product
68094-081-01Product
68094-081-25Product
84769-0001-1Product
84769-0001-2Product
84769-0002-1Product
84769-0002-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
