CLASS II ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
Gas-X, Simethicone 125 mg/ Antigas recalled by Haleon US Holdings
Haleon US Holdings is recalling Gas-X, Simethicone 125 mg/ Antigas, distributed nationwide in the US. The recall was initiated on 11 May 2026 and the FDA has classified it as Class II.
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-0542-2026
- FDA event ID
- 98910
- Recalling firm
- Haleon US Holdings, Warren, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 May 2026
- FDA classified
- 19 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 11 May 2026 | Recall initiated by company | |
| 19 May 2026 | Classified by FDA | +8 days |
| 27 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Product as listed by the FDA
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Which lots are affected?
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Where was it sold?
U.S. Nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 I | Gas-X Extra Strength, Simethicone 125 mg/Antigas recalled | Haleon US Holdings | Packaging Defects | 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 |