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
- Category
- Drug — Topical OTC
- 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.
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