LEO PHARMA INC

FDA Regulatory Profile

LEO PHARMA INC appears in FDA public data with 3 recalls, 0 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0339-2026, Class II) was initiated on February 10, 2026.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0339-2026Class IIAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLFebruary 10, 2026
D-0510-2017Class IICalcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-87January 19, 2017
D-0477-2017Class IIITaclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packagedJanuary 16, 2017