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.

Menthocin Patch with Lidocaine-Strong (Menthol 5% Recalled by Bonita Pharmaceuticals, LLC Due to Marketed without an approved NDA/ANDA

Date: January 27, 2016
Company: Bonita Pharmaceuticals, LLC
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 Bonita Pharmaceuticals, LLC directly.

Affected Products

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15

Quantity: 3,308 boxes

Why Was This Recalled?

Marketed without an approved NDA/ANDA

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bonita Pharmaceuticals, LLC

Bonita Pharmaceuticals, LLC has 1 total recall tracked by RecallDetector.

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