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FDA DrugsClass II

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Published: March 11, 2026Recall ID: D-0387-2026Category: Drugs & MedicineCountry: United States
US
PharmaceuticalFDA DrugsUSUS

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Recalling Firm: HTO Nevada Inc. dba Kirkman

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Translate NoticeTranslate notice text, hazard warnings, and descriptions into any supported language.

Reason for Recall / Hazard

Stability Data Does Not Support Expiry Date.

Product Description & Identification

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Affected Products

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Additional Source Details

FieldValue
CityLake Oswego
StateOR
Event id98494
Address 16400 Rosewood St
Address 2N/A
Code infoLot #: 795CP-0005, Exp. Date 06/30/2026
Postal code97035-5392
Report date20260311
Product typeDrugs
Product quantity243 bottles
Reason for recallStability Data Does Not Support Expiry Date.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260218
Initial firm notificationE-Mail
Center classification date20260305

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 MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Sourc...?

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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Overview

  • Recalling FirmHTO Nevada Inc. dba Kirkman
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the U.S
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

📢 Share Warning

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

🚨 SAFETY ALERT: HTO Nevada Inc. dba Kirkman - MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Check if your household is affected:
https://therecallfile.com/recalls/maximum-zone-2-4-lidocaine-cream-lidocaine-4-and-epinephrine-0-01-1-oz/FDA-D-0387-2026
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