FDA Drug recall D-0426-2025
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Dist…
- FDA Drug
- Class II
- terminated
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Dist… by Kenil Healthcare Private, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0426-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-04-24 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kenil Healthcare Private |
| Distribution | DE, NC |
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.
Reason
CGMP Deviations
Identifiers
| upc | 899711001013 |
|---|---|
| ndc | 55758-109-02 |
| code_info | Lot SP30A, Exp Date: 09/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0426-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.