Winder Laboratories, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
8
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0223-2026Class IIIMorphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, ManufNovember 26, 2025
D-0545-2024Class IIPhenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder LaboratMay 28, 2024