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Haleon US Holdings LLC FDA Recalls
6 recalls on file across drugs, 3 of them Class I and 4 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC Class IJun 4, 2026Chemical Contamination: contamination with a diluted propyle |
| Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.Class IIMay 11, 2026Labeling: Not Elsewhere Classified- Incomplete inactive ingr |
| parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by HaleClass IIIDec 26, 2025Labeling: Incorrect or Missing Lot and/or Exp Date: Potentia |
| Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh MinClass IIIAug 5, 2025Labeling: Label Mix-up: The outer carton is labelled Fresh M |
| Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, DistrClass IDec 26, 2023Microbial Contamination of Non-Sterile Products |
| Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 Class IDec 26, 2023Microbial Contamination of Non-Sterile Products |