FDA-Drug2026-05-27Class IIMISBRANDING
Gas-X Simethicone 125 mg recalled for incomplete inactive ingredient labeling
What this means
Gas-X Simethicone 125 mg softgels distributed by Haleon are being recalled because the carton labeling does not list all inactive ingredients. This affects three specific lot codes (KB5Y, MP4B, and SS4F) distributed nationwide.
- Check your Gas-X Simethicone 125 mg box for the affected lot codes: KB5Y (expires 04/2028), MP4B (expires 05/2028), or SS4F (expires 09/2028).
- If you have an affected lot and have concerns about ingredients—especially if you have allergies—contact Haleon or speak with a pharmacist.
- Contact Haleon with questions about the missing ingredient information.
The agency's original wording
Hazard
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide.
Affected count
285,330 blister cards
Manufactured in
184 Liberty Corner Rd Ste 200, Warren, NJ, United States
Products
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2026More Haleon recalls
- FDA-Drug2026-06-17Gas-X Extra Strength recalled for propylene glycol coolant contamination
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