Topical Salicylic Acid Drug Recalled Over Manufacturing Process Deviations
Kingskin SacaCallos (17% salicylic acid solution) is being recalled due to manufacturing process deviations. The recalled product was distributed in Delaware and North Carolina.
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: This is an FDA Class II recall for manufacturing process deviations with no reported illnesses or injuries. The hazard is procedural rather than a specific identified contamination or defect.
Plain-English summary
Kingskin, SacaCallos, containing 17% salicylic acid in a 0.5 fl oz (14.8 mL) bottle, is being recalled by KENIL HEALTHCARE PRIVATE LIMITED due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process.
This is an FDA Class II recall. The product was manufactured in India and distributed by Pharmadel LLC (New Castle, Delaware) to Delaware and North Carolina. The affected lot is SP28A with an expiration date of September 30, 2026. Approximately 9,000 bottles are subject to recall.
Consumers who have purchased this product should discontinue use and contact their healthcare provider or the distributor. The recall was initiated by the manufacturer on April 24, 2025, and was terminated on February 19, 2026.
The recalled product
- Product
- 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.
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical
- Hazard
- cgmp-deviation
- manufacturing-issue
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 (2)
- Lot SP28A
- Exp Date: 09/30/2026
Distribution
Distributed in 2 states:
- DE
- NC
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