HTO Nevada Inc. Recalls Zone 2 Lidocaine Cream Over Stability Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
HTO Nevada Inc. dba Kirkman has issued a voluntary recall for 243 bottles of Zone 2 4% Lidocaine Cream because stability data does not support the labeled expiration date.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
HTO Nevada Inc. dba Kirkman has initiated a voluntary recall of its MAXIMUM, ZONE 2, 4% Lidocaine Cream. The recall was triggered after it was determined that the stability data for the product does not support the listed expiration date. This Class II recall was officially classified by the FDA on March 5, 2026.
Which Products Are Affected
The recall involves 243 bottles of the following product:
- Product Name: MAXIMUM, ZONE 2, 4% Lidocaine Cream (Lidocaine 4% and Epinephrine 0.01%)
- Size: 1 oz bottles
- NDC: 80069-015
- Lot Number: 795CP-0005
- Expiration Date: 06/30/2026
- Distributor: Dermal Source, Portland, OR 97232
The product was distributed nationwide within the United States.
What You Should Do
Consumers who possess the affected lot of Zone 2 Lidocaine Cream should stop using the product immediately. For information regarding returns or further instructions, consumers may contact the recalling firm, HTO Nevada Inc. dba Kirkman, located at 6400 Rosewood St, Lake Oswego, OR 97035.
Why This Matters
When stability data does not support an expiration date, the product may not maintain its labeled potency or safety standards throughout its intended shelf life. This can lead to reduced effectiveness of the medication.
Source
Information provided by the FDA under recall number D-0387-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.