Recall
FDAHealthMay 11, 2026

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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 11, 2026

U.S. Nationwide.

What's affected?

Product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Lot code
KB5Y

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 285,330 blister cards.

View original FDA notice →

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