← FDA ENFORCEMENT
D-0424-2025Class II
KENIL HEALTHCARE 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
KENIL HEALTHCARE PRIVATE LIMITED
Product type
Drug
Status
Terminated
Report date
2025-05-28
Distribution
DE and NC
Firm state
N/A
Product quantity
9,000 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
Product description
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
Code / lot info
Lot SP28A, Exp Date: 09/30/2026
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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 →