Haleon US Holdings LLC

FDA Regulatory Profile

Summary

Total Recalls
4 (2 Class I)
510(k) Clearances
0
Inspections
13
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0297-2026Class IIIparodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),December 26, 2025
D-0592-2025Class IIISensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for SensitAugust 5, 2025
D-0317-2024Class IRobitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (2December 26, 2023
D-0316-2024Class IRobitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL December 26, 2023