HTO Nevada Inc. Issues Recall for Maximum Zone 1 Lidocaine Cream Due to Stability Concerns
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HTO Nevada Inc. dba Kirkman is voluntarily recalling 178 bottles of Maximum Zone 1 4% Lidocaine Cream because stability data does not support the listed 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.
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What Happened
HTO Nevada Inc. dba Kirkman has initiated a voluntary recall of Maximum Zone 1 4% Lidocaine Cream. The recall was issued because the firm's stability data does not support the expiration date currently printed on the product packaging. This recall has been classified by the FDA as a Class II recall.
Which Products Are Affected
The recall involves 178 bottles of the following product:
- Product Name: MAXIMUM, ZONE 1, 4% Lidocaine Cream
- Size: 1/2 oz bottles
- NDC: 80069-014
- Lot Number: 807CP-0003
- Expiration Date: 07/31/2026
- Distributor: Dermal Source, Portland, OR
These products were distributed nationwide within the United States.
What You Should Do
Consumers who possess the affected lot of Maximum Zone 1 Lidocaine Cream should stop using the product immediately. For further information regarding returns or questions about the recall, consumers may contact HTO Nevada Inc. dba Kirkman, located in Lake Oswego, Oregon.
Why This Matters
Stability testing is essential to ensure that a medication maintains its labeled potency and safety throughout its entire shelf life. When stability data fails to support an expiration date, the product's effectiveness and safety profile cannot be guaranteed through that date.
Source
Information provided by the FDA. Recall Number: D-0386-2026.
Original source: FDA Official Notice ↗
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