MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Summary
The FDA issued a Class II for MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour by HTO Nevada Inc. dba Kirkman. Reason: Stability Data Does Not Support Expiry Date..
Details
Source
Drug Recall
External ID
D-0386-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Lot/Code Info: Lot #: 807CP-0003, Exp. Date 07/31/2026.
Quantity Affected: 178 bottles
Reason for Recall
Stability Data Does Not Support Expiry Date.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-18
Company
Lake Oswego, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
HTO Nevada Inc. dba Kirkman has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HTO Nevada Inc. dba Kirkman) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HTO Nevada Inc. dba Kirkman have FDA actions?
HTO Nevada Inc. dba Kirkman has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0386-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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