--- title: "Haleon US Holdings LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Haleon US Holdings LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/haleon-us-holdings-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Haleon US Holdings LLC recall records **6** reported ongoing 6 records in this archive. Latest source date Jun 4, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 4, 2026 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0595-2026-gas-x-extra-strength-simethicone-125-mg-antigas-packaged-in-a-120-softgels-upc-3-00674-35041-9-b-72/) Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0595-2026%22) May 11, 2026 FDA drug enforcement ### [Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.](https://isitonrecall.com/recall/fda-drug-d-0542-2026-gas-x-simethicone-125-mg-antigas-120-softgels-distributed-by-haleon-warren-nj-07059-upc-3-00674-3504/) Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. Class II Reported ongoing Distribution: U.S. Nationwide. [Official source for Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0542-2026%22) Dec 26, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0297-2026-parodontax-cetylpyridinium-chloride-active-gum-health-mouthwash-mint-net-wt-16-9-fl-oz-500-ml-distri/) Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. Class III Reported ongoing Distribution: Nationwide in the USA [Official source for parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 m...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0297-2026%22) Aug 5, 2025 FDA drug enforcement ### [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 cas...](https://isitonrecall.com/recall/fda-drug-d-0592-2025-sensodyne-pronamel-potassium-nitrate-5-sodium-fluoride-0-25-active-shield-toothpaste-for-sensitive-t/) 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 Class III Reported ongoing Distribution: Nationwide in the USA. [Official source for Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sen...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0592-2025%22) Dec 26, 2023 FDA drug enforcement ### [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 Heal...](https://isitonrecall.com/recall/fda-drug-d-0316-2024-robitussin-honey-cf-max-non-drowsy-adult-acetaminophen-650mg-dextromethorphan-hbr-20-mg-a-4-fl-oz-11/) Microbial Contamination of Non-Sterile Products Class I Reported ongoing Distribution: USA nationwide [Official source for Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0316-2024%22) Dec 26, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0317-2024-robitussin-honey-cf-max-nighttime-adult-acetaminophen-650-mg-diphenhydramine-hcl-25mg-8-fl-oz-237-ml/) Microbial Contamination of Non-Sterile Products Class I Reported ongoing Distribution: USA nationwide [Official source for Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0317-2024%22) ## Reasons in these listed records - Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. - Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. - Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. - 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 These examples come from this result page and are not a ranking of every recall reason. ## Checking Haleon US Holdings LLC ### Is there a recall on haleon us holdings llc right now? This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Haleon US Holdings LLC](https://isitonrecall.com/check/?q=Haleon%20US%20Holdings%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)