The Recall Desk
ModerateFDA (Drugs)·D-0381-2025·Announced 2025-04-30

Kingskin Salicylic Acid Wart Removal Recall Due to cGMP Deviations

Pharmadel, LLC is recalling Kingskin salicylic acid wart-removal solution due to cGMP manufacturing deviations. The recall affects 20,048 bottles distributed in Delaware.

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: The FDA classified this as a Class II recall, and the source text states no illnesses or injuries have been reported. The hazard is a manufacturing deviation without evidence of actual harm, placing it in the Moderate category.

Plain-English summary

Pharmadel, LLC is recalling Kingskin (Salicylic Acid), a topical over-the-counter drug product used for the removal of common warts. The product is a 0.50 fl oz (15 mL) liquid solution bearing NDC 55758-409-15 and distributed from the company's facility in New Castle, Delaware.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. This is a voluntary, firm-initiated recall.

The affected product consists of 20,048 bottles distributed in Delaware. Affected lot numbers and expiration dates are: KSE-01 (EXP: OCT 26) and KSE-02 (EXP: FEB 27).

Consumers who have purchased this product should stop use. Consult with a pharmacist or healthcare provider with questions about alternative wart-removal treatments.

The recalled product

Product
KINGSKIN (SALICYLIC ACID)
Brand
KINGSKIN
Manufacturer
Pharmadel, LLC
Hazard
  • cgmp-deviation
  • 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 (5)

  • Lot
  • expiry: KSE-01
  • EXP: OCT 26
  • KSE-02
  • EXP: FEB 27

Distribution

Distributed in 1 state:

  • DE