FDA Drug · D-0425-2025

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.

Class II · Terminated

CGMP Deviations

Affected lots / codes — check yours against thisLost SP21A, Exp Date: 03/31/2026

Recalling firm: KENIL HEALTHCARE PRIVATE LIMITED, Ta. Kadi, District Mehsana, N/A
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 16,248 Jars
Distribution: DE and NC
Recall initiated: April 24, 2025
Classified: May 19, 2025
Terminated: February 19, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0425-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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