← FDA ENFORCEMENT
D-0072-2025Class II
Unexo Life Sciences Private Limited
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Unexo Life Sciences Private Limited
Product type
Drug
Status
Terminated
Report date
2024-12-04
Distribution
Nationwide in the US
Product quantity
28,864 patches
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP Deviations
Product description
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
Code / lot info
UPC 8 59424 00433 6
Other recalls SPEQ maps to Risk Management & CAPA
2026-10-21Class IIHouston Rx LLC2026-10-21Class IICook Incorporated2026-10-21Class IIBaxter Healthcare Corporation2026-10-14Class IIQUANTUM OPS Inc
See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →