FDAClass IIRecall started May 11, 2026

Gas-X Recall: Labeling Error

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

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Gas-X recalled?

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

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

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

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

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

Which lot codes, UPCs or models are affected?

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

Agency record number
D-0542-2026
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 started
May 11, 2026
Report date
May 27, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls