← FDA ENFORCEMENT
D-0542-2026Class II

Haleon US Holdings LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Haleon US Holdings LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-27
Distribution
U.S. Nationwide.
Firm state
NJ
Product quantity
285,330 blister cards
Initiated by
Voluntary: Firm initiated
Reason for recall

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Product description

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Code / lot info

Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.

Data: U.S. FDA. 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. Open the enforcement explorer →