Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Summary
The FDA issued a Class II for Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren by Haleon US Holdings LLC. Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling..
Details
Source
Drug Recall
External ID
D-0542-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
Product Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Lot/Code Info: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Quantity Affected: 285,330 blister cards
Reason for Recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-11
Company
Warren, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0542-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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