Warren, NJ, United States
Haleon US Holdings LLC recalls
5 recalls recorded since 2018, most recently on 4 June 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)2
Ongoing Class I Drugs
- Recall started
- 4 June 2026
- Reason
- Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0595-2026
- Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Ongoing Class II Drugs
- Recall started
- 11 May 2026
- Reason
- Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0542-2026
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Ongoing Class III Drugs
- Recall started
- 26 December 2025
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0297-2026
- parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Ongoing Class III Drugs
- Recall started
- 5 August 2025
- Reason
- Labeling: 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 carton
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0592-2025
- Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare,
Terminated Class I Drugs
- Recall started
- 26 December 2023
- Terminated
- 5 October 2026
- Reason
- Microbial Contamination of Non-Sterile Products
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0317-2024, D-0316-2024
- Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.