Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Maximum Zone2 Topical Analgesic Recalled by HTO Nevada, Inc. Due to cGMP Deviation: Raw material recalled by repackager, due...

Date: February 9, 2023
Company: HTO Nevada, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact HTO Nevada, Inc. directly.

Affected Products

Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).

Quantity: 1,571 bottles

Why Was This Recalled?

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About HTO Nevada, Inc.

HTO Nevada, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report