Haleon US Holdings recalls
FDA enforcement reports naming Haleon US Holdings LLC as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 3
- Most recent report
- Jun 17, 2026
- Jun 17, 2026Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00…Drug · Haleon US Holdings LLCChemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.Class I
- May 27, 2026Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059Drug · Haleon US Holdings LLCLabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.Class II
- Feb 4, 2026parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, MintDrug · Haleon US Holdings LLCLabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.Class III
- Aug 27, 2025Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0Drug · Haleon US Holdings LLCLabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer cartonClass III
- Jan 31, 2024Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20…Drug · Haleon US Holdings LLCMicrobial Contamination of Non-Sterile ProductsClass I
- Jan 31, 2024Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg…Drug · Haleon US Holdings LLCMicrobial Contamination of Non-Sterile ProductsClass I