CLASS I ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
Gas-X Extra Strength, Simethicone 125 mg/Antigas recalled
Haleon US Holdings is recalling Gas-X Extra Strength, Simethicone 125 mg/Antigas, distributed nationwide in the US. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0595-2026
- FDA event ID
- 99125
- Recalling firm
- Haleon US Holdings, Warren, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 17 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +13 days |
| 17 Jun 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Which lots are affected?
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Haleon US Holdings
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gas-X, Simethicone 125 mg/ Antigas recalled by Haleon US Holdings | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | parodontax (cetylpyridinium chloride)Active Gum Health recalledParodontax | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | Sensodyne Pronamel (Potassium nitrate recalled by Haleon US Holdings | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Non-Drowsy Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Nighttime Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |