HTO Nevada Inc. Recalls Zone 2 Lidocaine Cream Over Stability Concerns
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 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.
Source: FDA Official Notice