Haleon recalls Gas-X Simethicone 125 mg 120-count softgels because the carton lists incomplete inactive ingredients
The carton label does not list all of the inactive ingredients in these Gas-X softgels, which matters to anyone who needs to avoid a certain ingredient.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Company
- Haleon US Holdings LLC
- Hazard
- Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- Units
- 285,330 blister cards
- Where sold
- U.S. Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 19, 2026
- Recall started
- May 11, 2026
- FDA enforcement report
- May 27, 2026
- Identifiers
- Codes: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
- FDA recall number: D-0542-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Reason for recall
- Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- Classification
- Class II (Ongoing)
- Distribution
- U.S. Nationwide.
- Quantity
- 285,330 blister cards
Related recalls
Haleon recalls Gas-X Extra Strength softgels over coolant contamination from a packaging machine leak
The softgels may be contaminated with a diluted propylene glycol-based coolant that leaked from a machine during packaging.
Haleon US Holdings LLC · 35,883 boxes/carton