KOFAL Original recall
FDA recall D-0425-2025 · initiated Apr 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED recalled KOFAL Original in Apr 2025 — an FDA Class II recall (D-0425-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 16,248 Jars
Details
- 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.
- Recalling company
- KENIL HEALTHCARE PRIVATE LIMITED
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- DE and NC
- Initiated
- Apr 24, 2025
- FDA report date
- May 28, 2025
Frequently asked
- Was KOFAL Original recalled?
- KENIL HEALTHCARE PRIVATE LIMITED recalled KOFAL Original in Apr 2025 — an FDA Class II recall (D-0425-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was KOFAL Original recalled?
- Per the FDA enforcement record, the reason for recall D-0425-2025 was: CGMP Deviations
- Is a recalled KOFAL Original dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of KOFAL Original are affected?
- Distributed: DE and NC. The recall covers these lots — Lost SP21A, Exp Date: 03/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0425-2025.