Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 24, 2025 (1 years ago)

Kingskin

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

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.

Affected NDC 55758-0423-15

Compare with the code on your package — it is the most precise check available.

Recalling firm
Kenil Healthcare Private Limited
NDC code
55758-423-15
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0424-2025 · 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.

Other recalls by Kenil Healthcare Private Limited

All 2025 recalls
Class II · Moderate risk

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Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-05 D-0440-2025
Class II · Moderate risk

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Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-07 D-0437-2025

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Ongoing cGMP deviation Gold Star Distribution INC D-0286-2026