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FDAClass II

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 0705… Recalled: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the car…

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels,… was recalled on May 11, 2026 in cooperation with the U.S. Food and Drug Administration because labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling..

Is my unit affected?

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Model, lot & date codes to check

Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.

Units affected: 285,330 blister cards

Where it was sold: U.S. Nationwide.

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Haleon US Holdings LLC

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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