FDA·Medicines·May 27, 2026

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.
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

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