Haleon recalls Gas-X Extra Strength softgels over coolant contamination from a packaging machine leak
The softgels may be contaminated with a diluted propylene glycol-based coolant that leaked from a machine during packaging.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- 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.
- Company
- Haleon US Holdings LLC
- Hazard
- Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- Units
- 35,883 boxes/carton
- Where sold
- Nationwide within the United States
- FDA classification
- Class I · Ongoing
- Classified by FDA
- June 17, 2026
- Recall started
- June 4, 2026
- FDA enforcement report
- June 17, 2026
- Identifiers
- Codes: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
- FDA recall number: D-0595-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Classification
- Class I (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 35,883 boxes/carton
Related recalls
Haleon recalls Gas-X Simethicone 125 mg 120-count softgels because the carton lists incomplete inactive ingredients
The carton label does not list all of the inactive ingredients in these Gas-X softgels, which matters to anyone who needs to avoid a certain ingredient.
Haleon US Holdings LLC · 285,330 blister cards