Class II · Moderate risk Ongoing
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Reason Failed Stability Specifications
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
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.
- Recalling firm
- Kenil Healthcare Private Limited
- NDC code
- 55758-423-15
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0424-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Salicylic recalls
See all
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser…
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Class II · Moderate risk Terminated
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle…
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Class II · Moderate risk Completed
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC…
Reason cGMP Deviations
Class III · Low risk Terminated
Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6…
Reason Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
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