← FDA ENFORCEMENT
D-0595-2026Class I

Haleon US Holdings LLC

Recalling firm
Haleon US Holdings LLC
Product type
Drug
Status
Ongoing
Report date
2026-06-17
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
35,883 boxes/carton
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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.

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.