The Recall Desk
ModerateFDA (Drugs)·D-0386-2026·Announced 2026-03-11

Zone 1 lidocaine cream recalled because stability data does not support expiry

HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 1 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

What this means for you

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 1 4% Lidocaine Cream in 1/2 oz bottles, distributed by Dermal Source of Portland, Oregon, NDC 80069-014. About 178 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 807CP-0003 with an expiry date of 07/31/2026.

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 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Manufacturer
HTO Nevada Inc. dba Kirkman
Category
Drug — Topical anaesthetic
Hazard
  • stability-failure
  • expiry-dating
  • labelling-error

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 #: 807CP-0003
  • Exp. Date 07/31/2026.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category