The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Drug — Topical OTC
Hazard
Affected units
20,048

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:

Part of a larger recall action

This product is one of 6 recalled by Pharmadel, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Pharmadel, LLC

See all →

Same hazard · cgmp deviation

See all →

Similar recalls