Recall: D-0542-2026

Class II - Potentially Harmful

Class IIClassification
2026-05-11Initiated
OngoingStatus
Haleon US Holdings LLCFirm

Product

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.

Distribution

U.S. Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.