Calcipotriene Cream 0 — Class II drug recall D-0510-2017
Terminated recall by LEO PHARMA INC, reported 2017-03-15, distributed nationwide. Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic labe
| Recall number | D-0510-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEO PHARMA INC, Madison, NJ, United States |
| Recall initiated | 2017-01-19 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2018-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 272,062 tubes |
| Reason classes | undeclared allergen, labeling |
| NDC | 66993-0877, 66993-0877-61, 66993-0877-78 |
Product
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
Reason for recall
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.
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-0510-2017. 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.