Accueil/Tous les Rappels/FDA-D-0532-2026
FDA DrugsClass II

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)

Publié le: 22 avril 2026ID du rappel: D-0532-2026Catégorie: Médicaments & SantéPays: États-Unis
US
PharmaceuticalFDA DrugsUSUS

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)

Recalling Firm: Huons Co., Ltd.

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Lack of Assurance of Sterility

Description du produit & 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
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Openfda › Upc › 40373293000416
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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

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co.,...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Aperçu

  • Entreprise responsableHuons Co., Ltd.
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionUSA Nationwide.
Recall Hazard Severity
High Alert (Class I)
Alerte officielle de l’agence

📢 Partager l’alerte

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: Huons Co., Ltd. - 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)

Check if your household is affected:
https://therecallfile.com/fr/recalls/lidocaine-hcl-injection-usp-2-100-mg-5ml-20-mg-ml-5-ml-single-dose-via/FDA-D-0532-2026
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Spread the WordLidocaine 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)

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