Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calcipotriene Cream 0.0005% Recalled by LEO PHARMA INC Due to Undeclared Excipients
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LEO PHARMA INC directly.
Affected Products
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
Quantity: 272,062 tubes
Why Was This Recalled?
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LEO PHARMA INC
LEO PHARMA INC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report