Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension Recalled by LEO PHARMA INC Due to Labeling: Incorrect or missing package insert: the affected...

Date: January 16, 2017
Company: LEO PHARMA INC
Status: Terminated
Source: FDA (Drug)

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

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.

Quantity: 189,610 units

Why Was This Recalled?

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LEO PHARMA INC

LEO PHARMA INC has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report