The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0385-2026·Announced 2026-03-11

Vasocaine lidocaine spray recalled because stability data does not support expiry

HTO Nevada, trading as Kirkman, is recalling Five-Star Vasocaine Spray 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 FIVE-STAR VASOCAINE Spray (Lidocaine HCl 4%, Racepinephrine HCl 0.01%) in 4 oz bottles, distributed by Dermal Source of Portland, Oregon, NDC 80069-016. About 27,380 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 covers lots 839CP-0016 through 839CP-0024, with expiry dates running from 03/31/2026 to 07/31/2028.

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

The recalled product

Product
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Manufacturer
HTO Nevada Inc. dba Kirkman
Category
Drug — Topical anaesthetic
Hazard
Affected units
27,380

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 (18)

  • Lot #: 839CP-0016
  • Exp. Date 03/31/2026
  • 839CP-0017
  • Exp. Date 06/30/2026
  • 839CP-0018
  • Exp. Date 08/31/2026
  • 839CP-0019
  • Exp. Date 10/31/2026
  • 839CP-0020
  • Exp. Date 03/31/2027
  • 839CP-0021
  • Exp. Date 07/31/2027
  • 839CP-0022
  • Exp.Date 11/30/2027
  • 839CP-0023
  • Exp. Date 02/29/2028
  • 839CP-0024
  • Exp. Date 07/31/2028.

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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