D-0542-2026Class II

Haleon US Holdings LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-05-27

Distribution

U.S. Nationwide.

Firm state

Product quantity

285,330 blister cards

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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.

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See all Documentation & Change Control 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.