Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059… recall
FDA recall D-0542-2026 · initiated May 11, 2026
Haleon US Holdings LLC recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… in May 2026 — an FDA Class II recall (D-0542-2026) because Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 285,330 blister cards
Details
- Product
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Recalling company
- Haleon US Holdings
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- May 11, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… recalled?
- Haleon US Holdings LLC recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… in May 2026 — an FDA Class II recall (D-0542-2026) because Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… recalled?
- Per the FDA enforcement record, the reason for recall D-0542-2026 was: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- Is a recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren… are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0542-2026.