Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packa...

FDA Drug Recall #D-0477-2017 — Class III — January 16, 2017

Recall Summary

Recall Number D-0477-2017
Classification Class III — Low risk
Date Initiated January 16, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm LEO PHARMA INC
Location Madison, NJ
Product Type Drugs
Quantity 189,610 units

Product Description

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.

Reason for Recall

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Distribution Pattern

Nationwide within US

Lot / Code Information

Lot #: (a): EK9025, Exp. 2/28/2017; EL1057, Exp. 3/31/2017; EL4637, Exp. 6/30/2017; EM0825B, Exp. 11/30/2017; EM3992, Exp. 1/31/2019; A22902, Exp. 5/31/2019; A31838, Exp. 9/30/2019 Lot #:EK7007A, EK7007AA, Exp. 1/31/2017; EL2024, EL2979, Exp. 5/31/2017; EL8069, Exp. 10/31/2017; EA20780AA, Exp. 5/31/2019.

Other Recalls from LEO PHARMA INC

Recall # Classification Product Date
D-0339-2026 Class II Adbry, (tralokinumab-ldrm) injection, 300 mg/2m... Feb 10, 2026
D-0510-2017 Class II Calcipotriene Cream 0.0005%, packaged in a) 60g... Jan 19, 2017

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.