FDAClass IIMay 27, 2026

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels recall: Labeling Error

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

Why was Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Recalling firm
Haleon US Holdings LLC
Quantity
285,330 blister cards
Distribution
U.S. Nationwide.
Recall date
May 27, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls