The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0387-2026·Announced 2026-03-11

Zone 2 lidocaine cream recalled because stability data does not support expiry

HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 2 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers minor labelling errors: the fault is an expiry date the stability data does not support, and the source describes no hazard, illness or injury.

Plain-English summary

HTO Nevada Inc., trading as Kirkman, is recalling MAXIMUM ZONE 2 4% Lidocaine Cream (Lidocaine 4% and Epinephrine 0.01%) in 1 oz bottles, distributed by Dermal Source of Portland, Oregon, NDC 80069-015. About 243 bottles were distributed nationwide within the United States. The FDA has classified this recall as Class II.

The recall was initiated because the stability data does not support the expiry date. The source record does not describe a specific hazard, illness or injury.

Affected product is lot 795CP-0005 with an expiry date of 06/30/2026.

Users can identify affected product by the NDC and lot number above, and may contact HTO Nevada Inc. for further information.

The recalled product

Product
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.
Manufacturer
HTO Nevada Inc. dba Kirkman
Category
Drug — Topical anaesthetic
Hazard
Affected units
243

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 795CP-0005
  • Exp. Date 06/30/2026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by HTO Nevada Inc. dba Kirkman under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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