Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Parche Leon Pain Relieving Hot Patch (Capsaicin, Camphor, Menthol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
Affected NDC
55758-0039-01
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Parche Leon Capsaicin, Camphor, Menthol NDC 55758-0039 |
CAPSAICIN .025 g/1; CAMPHOR (SYNTHETIC) 3 g/1; MENTHOL, UNSPECIFIED FORM 1.25 g/1 | Patch Topical |
Pharmadel LLC | OTC |
- Recalling firm
- Unexo Life Sciences Private Limited
- NDC code
- 55758-039-01
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0072-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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