Recalls / Class II
Class IID-0426-2025
Product
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.
- Brand name
- Kofal
- Generic name
- Methyl Salicylate
- Active ingredient
- Methyl Salicylate
- Route
- Topical
- NDC
- 55758-109
- FDA application
- M017
- Affected lot / code info
- Lot SP30A, Exp Date: 09/30/2026
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Manufacturer
- Pharmadel LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A N/A, India
Distribution
- Quantity
- 11,808 Jars
- Distribution pattern
- DE and NC
Timeline
- Recall initiated
- 2025-04-24
- FDA classified
- 2025-05-19
- Posted by FDA
- 2025-05-28
- Terminated
- 2026-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0426-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.