Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC
Summary
The FDA issued a Class I for Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (U by Haleon US Holdings LLC. Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process..
Details
Source
Drug Recall
External ID
D-0595-2026
Action Date
2026-06-17
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Quantity Affected: 35,883 boxes/carton
Reason for Recall
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-04
Company
Warren, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Haleon US Holdings LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Haleon US Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Haleon US Holdings LLC have FDA actions?
Haleon US Holdings LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0595-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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