Kingskin SacaCallos salicylic acid solution recalled for manufacturing deviations
Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.
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: This is an FDA Class II recall for CGMP deviations with no reported illnesses or injuries documented in the source. The classification reflects manufacturing process issues rather than confirmed product contamination or harm, consistent with a Moderate severity rating.
Plain-English summary
Kingskin SacaCallos, a 17% salicylic acid topical solution in 0.5 fl oz bottles, is being recalled. The product is manufactured by KENIL HEALTHCARE PRIVATE LIMITED and distributed by Pharmadel LLC of New Castle, Delaware.
The reason for the recall is current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. The affected lot is SP28A with an expiration date of 09/30/2026.
Approximately 9,000 bottles were distributed to Delaware and North Carolina. The recall was initiated voluntarily by the firm and has been classified as FDA Class II. Consumers who have purchased this product should stop using it and consult with their healthcare provider or pharmacist for guidance.
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 Solution
- Hazard
- Affected units
- 9,000
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
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED 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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