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 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, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.

Quantity: 11,808 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.

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