Class II U.S. Food and Drug Administration

Kirkman Maximum, Zone 2, 4% Lidocaine Cream, , 1 oz bottles recall: Stability Data Does Not Support Expiry Date

Recall published 8 months ago

Stability Data Does Not Support Expiry Date.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Stability Data Does Not Support Expiry Date.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0387-2026
Published
March 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Kirkman
Product type
Prescription & OTC drugs
Units affected
243 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 795CP-0005, Exp. Date 06/30/2026

Products covered by this recall

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 your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 795CP-0005
  • 30
  • 2026 — 243 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06
  • 30
  • 2026 — 243 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 80069-015

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 oz

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Kirkman — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: HTO Nevada Inc. dba Kirkman — 6400 Rosewood St, Lake Oswego, OR, 97035-5392

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Kirkman prescription & otc drugs recalled?

Stability Data Does Not Support Expiry Date. Stability Data Does Not Support Expiry Date.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 795CP-0005, 30, 2026 — 243 bottles; best-by date 06 or 30. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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