CLASS III Drug recall · Reported 22 Feb 2017 · FDA Enforcement Report
Taclonex (calcipotriene and betamethasone dipropionate) recalled
LEO Pharma is recalling Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, distributed nationwide in the US. The recall was initiated on 16 Jan 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0477-2017
- FDA event ID
- 76370
- Recalling firm
- LEO Pharma, Madison, NJ
- Brand
- Taclonex
- Manufacturer
- LEO Pharma Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jan 2017
- FDA classified
- 15 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Jan 2017 | Recall initiated by company | |
| 15 Feb 2017 | Classified by FDA | +30 days |
| 22 Feb 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within US
Questions about this recall
Why was it recalled?
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Which lots are affected?
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.
Where was it sold?
Nationwide within US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LEO Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Adbry, (tralokinumab-ldrm) injection, 300 mg recalled by Leo PharmaAdbry | LEO Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Calcipotriene Cream recalled by Leo PharmaCalcipotriene | LEO Pharma | Labeling Errors | Nationwide |
Other Calcipotriene recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Other | Nationwide |
| Drug | CLASS II | Calcipotriene Cream recalled by Leo PharmaCalcipotriene | LEO Pharma | Labeling Errors | Nationwide |