Taclonex — Class III drug recall D-0477-2017
Terminated recall by LEO PHARMA INC, reported 2017-02-22, distributed nationwide. Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package i
| Recall number | D-0477-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEO PHARMA INC, Madison, NJ, United States |
| Recall initiated | 2017-01-16 |
| Classified | 2017-02-15 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 189,610 units |
| Reason classes | labeling |
| NDC | 50222-0501, 50222-0501-06, 50222-0501-51, 50222-0501-66 |
| Lot numbers | A22902, A31838, EA20780AA, EK7007A, EK7007AA, EK9025, EL1057, EL2024, EL2979, EL4637, EL8069, EM0825B, EM3992 |
| Expiration dates | 2017-01-31, 2017-02-28, 2017-03-31, 2017-05-31, 2017-06-30, 2017-10-31, 2017-11-30, 2019-01-31, 2019-05-31, 2019-09-30 |
Product
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0477-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.