Warning
Haleon US Holdings LLC Recalls Gas-X
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0542-2026Drug / Pharmaceutical
Haleon US Holdings LLC Recalls Gas-X
Haleon US Holdings LLC · Class II — Moderate Risk
Product Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Reason for Recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Haleon US Holdings LLC initiated the recall on May 11, 2026 affecting 285,330 blister cards. Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. The product was distributed in U.S. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Haleon US Holdings LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.