Parche Leon pain relief patches recalled for manufacturing deviations
Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary, precautionary recall due to manufacturing practice deviations, with no reported illnesses or injuries. Per the severity rubric, recalls with no reported adverse events and theoretical hazards score at most 3; manufacturing-only concerns without reported harm qualify as Moderate.
Plain-English summary
Unexo Life Sciences Private Limited is recalling Parche Leon pain relief patches nationwide in the United States. The product is a topical over-the-counter medication containing camphor 3%, menthol 1.25%, and capsaicin 0.025%.
The recall was initiated on October 24, 2024, due to current good manufacturing practice (cGMP) deviations identified in the manufacturing process. The voluntary recall was terminated on September 16, 2025. A total of 28,864 patches have been affected.
No illnesses or injuries related to this product have been reported. The product is distributed by Pharmadel LLC of Georgetown, Delaware, and can be identified by UPC 8 59424 00433 6 and NDC 55758-039-01.
The recalled product
- Product
- PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL)
- Brand
- PARCHE LEON
- Manufacturer
- Unexo Life Sciences Private Limited
- Category
- Drug — Topical Pain Relief
- Hazard
- manufacturing-defect
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 (1)
- UPC 8 59424 00433 6
UPCs (1)
- 859424004336
Distribution
Distributed nationwide across the United States.
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