FDA Drug · D-0595-2026

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.

Class I · Ongoing

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

Affected lots / codes — check yours against thisLots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.

Recalling firm: Haleon US Holdings LLC, Warren, NJ
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 35,883 boxes/carton
Distribution: Nationwide within the United States
Recall initiated: June 4, 2026
Classified: June 17, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0595-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →