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.

KOFAL Original Recalled by KENIL HEALTHCARE PRIVATE LIMITED Due to CGMP Deviations

Date: April 24, 2025
Company: KENIL HEALTHCARE PRIVATE LIMITED
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 KENIL HEALTHCARE PRIVATE LIMITED directly.

Affected Products

KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.

Quantity: 16,248 Jars

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed to 2 states: DE, NC

Affected (2 states)Not affected

About KENIL HEALTHCARE PRIVATE LIMITED

KENIL HEALTHCARE PRIVATE LIMITED has 20 total recalls tracked by RecallDetector.

Related Recalls

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