Gas-X Extra Strength recall
FDA recall D-0595-2026 · initiated Jun 4, 2026
Haleon US Holdings LLC recalled Gas-X Extra Strength in Jun 2026 — an FDA Class I recall (D-0595-2026) because Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 35,883 boxes/carton
Details
- Product
- Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
- Recalling company
- Haleon US Holdings
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 4, 2026
- FDA report date
- Jun 17, 2026
Frequently asked
- Was Gas-X Extra Strength recalled?
- Haleon US Holdings LLC recalled Gas-X Extra Strength in Jun 2026 — an FDA Class I recall (D-0595-2026) because Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Gas-X Extra Strength recalled?
- Per the FDA enforcement record, the reason for recall D-0595-2026 was: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- Is a recalled Gas-X Extra Strength 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 Extra Strength are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.. 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-0595-2026.