The Recall Desk
HighFDA (Drugs)·D-0425-2025·Announced 2025-05-28

[pending] KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 o

Pending LLM rewrite. Source: FDA_DRUG D-0425-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

CGMP Deviations

The recalled product

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.
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lost SP21A
  • Exp Date: 03/31/2026

Distribution

Distributed in 2 states:

  • DE
  • NC