Recall archive / FDA drug enforcement
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Di... — FDA record D-0425-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- CGMP Deviations
- Classification
- Class II
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Quantity
- 16,248 Jars
- Agency-reported status
- Terminated
- Source record identifier
- D-0425-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lost SP21A, Exp Date: 03/31/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
DE and NC
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 28, 2025
- Recall initiation date
- Apr 24, 2025
- Center classification date
- May 19, 2025
- Termination date
- Feb 19, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.