Kofal Ointment
FDA Recall NDC 55758-109
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kofal (NDC 55758-109). A significant event, classified as Class II, was initiated on Apr 24, 2025 by Pharmadel Llc. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Apr 24, 2025
May 28, 2025
11,808 Jars
Recall Profile & Regulatory Data
Event ID
96797
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
DE and NC
Termination Date
Feb 19, 2026
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot SP30A, Exp Date: 09/30/2026
Affected Packages Involved in this Recall
55758-109-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
