KOFAL recalled over manufacturing violations

Recall date

April 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

KENIL HEALTHCARE PRIVATE LIMITED recalls KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2…

Recall number

D-0426-2025

FDA classification

Class II

Brand / firm

KENIL HEALTHCARE PRIVATE LIMITED

Sold / distributed

DE and NC

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.