Gas-X Simethicone 125 mg softgels recall for incomplete labeling
Haleon is recalling Gas-X Simethicone 125 mg softgels due to incomplete inactive ingredient information on carton labeling.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II labeling recall involving incomplete inactive ingredient information, a minor labeling deficiency. No illness, injury, or known harm is reported in the source text.
Plain-English summary
Haleon US Holdings LLC is recalling Gas-X Simethicone 125 mg/Antigas 120 softgels distributed nationwide due to incomplete inactive ingredient information on the carton labeling.
The affected product lots are KB5Y (expires 04/2028), MP4B (expires 05/2028), and SS4F (expires 09/2028). The product is identified by UPC 3 00674 35041 9.
Consumers with affected packages should discontinue use. Healthcare providers or consumers with questions can contact Haleon.
The recalled product
- Product
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Manufacturer
- Haleon US Holdings LLC
- Category
- Drug — Over-the-counter
- Hazard
- Affected units
- 285,330
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: KB5Y
- Expires: 04/2028
- MP4B
- Expires: 05/2028
- SS4F
- Expires: 09/2028.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Haleon US Holdings LLC
See all →- SevereGas-X Extra Strength softgels contaminated with propylene glycol machine coolant
FDA (Drugs) · 2026-06-17
- LowMouthwash recalled over missing or illegible lot and expiry coding
FDA (Drugs) · 2026-02-04
- LowSensodyne Pronamel toothpaste recalled after tube and carton labels were mixed up
FDA (Drugs) · 2025-08-27
- SevereRobitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination
FDA (Drugs) · 2024-01-31
- SevereRobitussin Honey CF Max Nighttime Adult Recalled for Microbial Contamination
FDA (Drugs) · 2024-01-31
Same hazard · labeling error
See all →- ModerateLiquid Hope Organic Meal Replacement Formula Subpotent Vitamin A Recall
FDA (Food) · 2026-07-22
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- Moderate
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24