Home/Recalls/FDA-D-0529-2026
FDA DrugsClass II

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx...

Published: April 22, 2026Recall ID: D-0529-2026Category: drugsCountry: US

Reason for Recall / Hazard

Lack of Assurance of Sterility

Product Description & Identification

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)

Additional Source Details

FieldValue
CityJecheon
StateN/A
Openfda › Upc › 10373293000317
Openfda › Upc › 20373293000522
Openfda › Upc › 30373293000119
Openfda › Upc › 40373293000416
Openfda › Upc › 50373293000423
Openfda › Upc › 60373293000126
Openfda › Upc › 70373293000324
Openfda › Upc › 80373293000515
Openfda › Upc › 90363739170247
Openfda › Upc › 100363739170131
Openfda › Upc › 110371351026255
Openfda › Upc › 120371351021250
Openfda › Upc › 130371351023254
Openfda › Upc › 140371351027252
Openfda › Upc › 150371351021106
Openfda › Upc › 160371351027207
Openfda › Upc › 170371351021052
Openfda › Upc › 180371351026200
Openfda › Upc › 190371351023100
Openfda › UniiV13007Z41A
Openfda › RouteINTRAVENOUS
Openfda › Rxcui › 11010033
Openfda › Rxcui › 21010671
Openfda › Rxcui › 31737566
Openfda › Rxcui › 41737761
Openfda › Spl id › 14711fd53-dad3-f117-e063-6394a90a8d3d
Openfda › Spl id › 22e9ea4d1-65b6-f07d-e063-6394a90a4b20
Openfda › Spl id › 3470c127d-31e7-0299-e063-6394a90a2ad0
Openfda › Spl id › 4302f313a-e838-a040-e063-6394a90ae806
Openfda › Brand nameLIDOCAINE HYDROCHLORIDE
Openfda › Spl set id › 18ec2d256-fc4f-44f6-bee2-eef2bf3bf580
Openfda › Spl set id › 2e1eabd6b-9bb8-646f-e053-2a95a90a7b83
Openfda › Spl set id › 3e824ba5b-3289-5ad4-e053-2995a90acc20
Openfda › Spl set id › 47567ffb5-953a-4be9-9a02-c5a50dcd9306
Openfda › Package ndc › 173293-0004-1
Openfda › Package ndc › 273293-0004-2
Openfda › Package ndc › 373293-0005-1
Openfda › Package ndc › 473293-0005-2
Openfda › Package ndc › 573293-0001-1
Openfda › Package ndc › 673293-0001-2
Openfda › Package ndc › 773293-0003-1
Openfda › Package ndc › 873293-0003-2
Openfda › Package ndc › 963739-170-13
Openfda › Package ndc › 1063739-170-24
Openfda › Package ndc › 1163739-170-27
Openfda › Package ndc › 1271351-026-20
Openfda › Package ndc › 1371351-026-25
Openfda › Package ndc › 1471351-027-20
Openfda › Package ndc › 1571351-027-25
Openfda › Package ndc › 1671351-021-05
Openfda › Package ndc › 1771351-021-10
Openfda › Package ndc › 1871351-021-25
Openfda › Package ndc › 1971351-023-05
Openfda › Package ndc › 2071351-023-10
Openfda › Package ndc › 2171351-023-25
Openfda › Package ndc › 2284769-0001-1
Openfda › Package ndc › 2384769-0001-2
Openfda › Package ndc › 2484769-0002-1
Openfda › Package ndc › 2584769-0002-2
Openfda › Product ndc › 173293-0001
Openfda › Product ndc › 273293-0004
Openfda › Product ndc › 373293-0005
Openfda › Product ndc › 473293-0003
Openfda › Product ndc › 563739-170
Openfda › Product ndc › 671351-021
Openfda › Product ndc › 771351-026
Openfda › Product ndc › 871351-027
Openfda › Product ndc › 971351-023
Openfda › Product ndc › 1084769-0001
Openfda › Product ndc › 1184769-0002
Openfda › Generic nameLIDOCAINE HYDROCHLORIDE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameLIDOCAINE HYDROCHLORIDE
Openfda › Manufacturer name › 1Huons Co., Ltd.
Openfda › Manufacturer name › 2McKesson Corporation dba SKY Packaging
Openfda › Manufacturer name › 3Brookfield Pharmaceuticals, LLC.
Openfda › Manufacturer name › 4Novagenix Labs LLC
Openfda › Application numberANDA212821
Openfda › Is original packagertrue
Event id98724
Address 1100 Bio-Valley-Ro
Address 2N/A
Code infoAll lots within expiry
Postal codeN/A
Report date20260422
Product typeDrugs
Product quantity33,599,925 ampules and 23658125 vials
Reason for recallLack of Assurance of Sterility
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260402
Initial firm notificationN/A
Center classification date20260515

Overview

  • Recalling FirmHuons Co., Ltd.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUSA Nationwide.
Official Agency Alert

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