Home/Recalls/FDA-D-0532-2026
FDA DrugsClass II

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials,...

Published: April 22, 2026Recall ID: D-0532-2026Category: drugsCountry: US

Reason for Recall / Hazard

Lack of Assurance of Sterility

Product Description & Identification

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)

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 › 90371351026255
Openfda › Upc › 100371351021250
Openfda › Upc › 110371351023254
Openfda › Upc › 120371351027252
Openfda › Upc › 130371351021106
Openfda › Upc › 140371351027207
Openfda › Upc › 150371351021052
Openfda › Upc › 160371351026200
Openfda › Upc › 170371351023100
Openfda › Upc › 180368094081252
Openfda › Upc › 190368094081016
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 › 2470c127d-31e7-0299-e063-6394a90a2ad0
Openfda › Spl id › 34711ae97-ff32-948e-e063-6394a90ae40d
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 › 2e824ba5b-3289-5ad4-e053-2995a90acc20
Openfda › Spl set id › 327b6ef54-a093-2bef-e063-6394a90a7912
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 › 971351-026-20
Openfda › Package ndc › 1071351-026-25
Openfda › Package ndc › 1171351-027-20
Openfda › Package ndc › 1271351-027-25
Openfda › Package ndc › 1371351-021-05
Openfda › Package ndc › 1471351-021-10
Openfda › Package ndc › 1571351-021-25
Openfda › Package ndc › 1671351-023-05
Openfda › Package ndc › 1771351-023-10
Openfda › Package ndc › 1871351-023-25
Openfda › Package ndc › 1968094-081-01
Openfda › Package ndc › 2068094-081-25
Openfda › Package ndc › 2184769-0001-1
Openfda › Package ndc › 2284769-0001-2
Openfda › Package ndc › 2384769-0002-1
Openfda › Package ndc › 2484769-0002-2
Openfda › Product ndc › 173293-0001
Openfda › Product ndc › 273293-0004
Openfda › Product ndc › 373293-0005
Openfda › Product ndc › 473293-0003
Openfda › Product ndc › 571351-021
Openfda › Product ndc › 671351-026
Openfda › Product ndc › 771351-027
Openfda › Product ndc › 871351-023
Openfda › Product ndc › 968094-081
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 › 2Brookfield Pharmaceuticals, LLC.
Openfda › Manufacturer name › 3Precision Dose, Inc.
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 quantityN/A
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

Related Recalls

Pharmaceutical
FDA DrugsClass II

Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma...

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

Jul 1, 2026Annora Pharma Private Limited
Pharmaceutical
FDA DrugsClass II

Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551...

Presence of Foreign Substance.

Jul 1, 2026Amgen, Inc.
Pharmaceutical
FDA DrugsClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Jul 1, 2026CareFusion 213, LLC