Haleon US Holdings LLC recalls
Every recall we track for Haleon US Holdings LLC — 6 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
6 recalls since 2017. 17% rated “stop using now”.
All FDA recall records for Haleon US Holdings LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 1 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 1 | 1 | 2 |
Most common reasons for Haleon US Holdings LLC recalls
What to do if you have a recalled Haleon US Holdings LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Haleon US Holdings LLC recalls
5 shown- UnratedDrug
Haleon US Holdings LLC recalls Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC
Haleon recalls Gas-X Extra Strength softgels due to potential chemical contamination from machine leakage during packaging. Affected lots expire Nov 2028. Consumers should check UPCs and lot numbers.
HaleonJun 4, 2026 - Lower riskDrug
Haleon US Holdings LLC recalls Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Haleon recalls Gas-X Simethicone 125mg 120-count softgels for incomplete inactive ingredient labeling on carton. Consumers should check product details and contact Haleon for more information.
HaleonMay 11, 2026 - Lower riskDrug
Haleon US Holdings LLC recalls parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by
Haleon recalls Parodontax 500mL mouthwash due to potential missing or illegible lot and expiration dates on bottles. Consumers should check labels for correct date coding.
HaleonDec 26, 2025 - Lower riskDrug
Haleon US Holdings LLC recalls Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh
Haleon recalls Sensodyne PRONAMEL toothpaste due to outer carton labeling as Fresh Mint but tube labeled Cool Mint/Whitening, causing confusion for consumers.
HaleonAug 5, 2025 - Stop using nowDrug
Haleon US Holdings LLC recalls Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle,
Haleon recalls Robitussin Honey CF Max Nighttime Adult bottles with microbial contamination risk. Affected lots expire June 2026. Consumers should stop using and contact Haleon for details.
HaleonDec 26, 2023
Haleon US Holdings LLC recall questions
How many recalls has Haleon US Holdings LLC had?
6 recalls from Haleon US Holdings LLC are on record with U.S. safety agencies, from 2023–2026.
What is the most recent Haleon US Holdings LLC recall?
Haleon US Holdings LLC recalls Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC, dated Jun 4, 2026. Every Haleon US Holdings LLC recall is listed on this page, newest first.
Why are Haleon US Holdings LLC products recalled?
The most common reasons on record: Microbial Contamination of Non-Sterile Products (2).
What should I do if I have a recalled Haleon US Holdings LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Haleon US Holdings LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.