HIGH

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.

Quick Facts at a Glance

Recall Date
May 11, 2026
Hazard Level
HIGH
Brand
Haleon US Holdings
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. Classification: Class II. Quantity: 285,330 blister cards. Distribution: U.S. Nationwide.

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot: KB5Y
Expires: 04/2028
MP4B
Expires: 05/2028
SS4F
+1 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE