D-0595-2026 Class I Ongoing

Recalled by Haleon US Holdings LLC — Warren, NJ

Recall Details

Product Type
Drugs
Report Date
June 17, 2026
Initiation Date
June 4, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35,883 boxes/carton

Product Description

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

Reason for Recall

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Distribution Pattern

Nationwide within the United States

Code Information

Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.